[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2369 Introduced in House (IH)]

<DOC>






118th CONGRESS
  1st Session
                                H. R. 2369

 To amend the Federal Food, Drug, and Cosmetic Act with respect to in 
             vitro clinical tests, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 29, 2023

  Mr. Bucshon (for himself and Ms. DeGette) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
  in addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to in 
             vitro clinical tests, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    (a) Short Title.--This Act may be cited as the ``Verifying Accurate 
Leading-edge IVCT Development Act of 2023'' or the ``VALID Act of 
2023''.

SEC. 2. DEFINITIONS.

    (a) In General.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended--
            (1) by adding at the end the following:
    ``(ss)(1) The term `in vitro clinical test' means an article 
specified in subparagraph (2) that is intended to be used in the 
collection, preparation, analysis, or in vitro clinical examination of 
specimens taken or derived from the human body for the purpose of--
            ``(A) identifying or diagnosing a disease or condition;
            ``(B) providing information for diagnosing, screening, 
        measuring, detecting, predicting, prognosing, analyzing, or 
        monitoring a disease or condition, including by making a 
        determination of an individual's state of health; or
            ``(C) selecting, monitoring, or informing therapy or 
        treatment for a disease or condition.
    ``(2) An article specified in this subparagraph is--
            ``(A) a test kit;
            ``(B) a test system;
            ``(C) a test protocol or laboratory test protocol;
            ``(D) an instrument (as defined in section 587(11));
            ``(E) a specimen receptacle (as defined in section 
        587(17));
            ``(F) software, excluding software that is excluded by 
        section 520(o) from the definition of a device under section 
        201(h), that--
                    ``(i) is a component or part of another in vitro 
                clinical test or analyzes, processes, or interprets a 
                signal or pattern from another in vitro clinical test; 
                and
                    ``(ii) does not analyze, process, or interpret a 
                signal, pattern, or medical image from a device; and
            ``(G) subject to subparagraph (3), a component or part of a 
        test kit, a test system, a test protocol or laboratory test 
        protocol, an instrument, a specimen receptacle, or software 
        described in subparagraph (F), whether alone or in combination, 
        including reagents, calibrators, and controls.
    ``(3) Notwithstanding subparagraph (2)(G), an article intended to 
be used as a component or part of an in vitro clinical test described 
in subparagraph (1) is excluded from the definition in subparagraph (1) 
if the article consists of any of the following:
            ``(A) Blood, blood components, or human cells or tissues, 
        from the time of acquisition, donation, or recovery of such 
        article, including determination of donor eligibility, as 
        applicable, until such time as the article is released as a 
        component or part of an in vitro clinical test by the 
        establishment that collected such article.
            ``(B) An article used for invasive sampling, a needle, or a 
        lancet, except to the extent such article, needle, or lancet is 
        an integral component of an article for holding, storing, or 
        transporting a specimen.
            ``(C) General purpose laboratory equipment.'';
            (2) by adding at the end of paragraph (g) the following:
    ``(3) The term `drug' does not include an in vitro clinical 
test.''; and
            (3) in paragraph (h)(1), in the matter following clause 
        (C), by striking ``section 520(o)'' and inserting ``section 
        520(o) or an in vitro clinical test''.
    (b) Exclusion From Definition of Biological Product.--Section 
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is 
amended--
            (1) by striking ``(1) The term `biological product' means'' 
        and inserting ``(1)(A) The term `biological product' means''; 
        and
            (2) by adding at the end the following:
            ``(B) The term `biological product' does not include an in 
        vitro clinical test as defined in section 201(ss) of the 
        Federal Food, Drug, and Cosmetic Act.''.
    (c) In Vitro Clinical Test Definition.--In this Act, the term ``in 
vitro clinical test'' has the meaning given such term in section 
201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a).

SEC. 3. REGULATION OF IN VITRO CLINICAL TESTS.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended--
            (1) by amending the heading of chapter V to read as 
        follows: ``DRUGS, DEVICES, AND IN VITRO CLINICAL TESTS''; and
            (2) by adding at the end of chapter V the following:

                ``Subchapter J--In Vitro Clinical Tests

``SEC. 587. DEFINITIONS.

    ``In this subchapter:
            ``(1) Analytical validity.--The term `analytical validity' 
        means, with respect to an in vitro clinical test, the ability 
        of the in vitro clinical test, to identify, measure, detect, 
        calculate, or analyze (or assist in such identification, 
        measurement, detection, calculation, or analysis of) one or 
        more analytes, biomarkers, substances, or other targets 
        intended to be identified, measured, detected, calculated, or 
        analyzed by the test.
            ``(2) Applicable standard.--The term `applicable standard', 
        with respect to an in vitro clinical test, means a reasonable 
        assurance of analytical and clinical validity for its 
        indications for use, and a reasonable assurance of safety for 
        individuals who come into contact with such in vitro clinical 
        test, except that such term, with respect to specimen 
        receptacles and test instruments, means a reasonable assurance 
        of analytical validity for its indications for use and safety 
        for individuals who come into contact with such specimen 
        receptacle or test instrument.
            ``(3) Clinical use.--The term `clinical use' means the 
        operation, application, or functioning of an in vitro clinical 
        test for the purpose for which it is intended as described in 
        section 201(ss)(1).
            ``(4) Clinical validity.--The term `clinical validity' 
        means the ability of an in vitro clinical test to achieve the 
        purpose for which it is intended as described in section 
        201(ss)(1).
            ``(5) Component or part.--The term `component or part' 
        means a substance, piece, part, raw material, software, 
        firmware, labeling, or assembly, including reagents, that is 
        intended to be included as an aspect of an in vitro clinical 
        test described in section 201(ss)(1).
            ``(6) Develop.--The term `develop', with respect to an in 
        vitro clinical test, means--
                    ``(A) designing, validating, producing, 
                manufacturing, remanufacturing, labeling, advertising, 
                propagating, importing, or assembling an in vitro 
                clinical test;
                    ``(B) modifying an in vitro clinical test, 
                including modifying the indications for use of the in 
                vitro clinical test, or modifying an article to be an 
                in vitro clinical test; or
                    ``(C) establishing a test system as described or 
                included in a test protocol developed by another entity 
                unless such test protocol is listed as an in vitro 
                clinical test in the comprehensive test information 
                system established under section 587T by that other 
                entity.
            ``(7) Developer.--The term `developer' means a person who 
        engages in development as described in paragraph (6), except 
        the term does not include a laboratory that--
                    ``(A) is certified by the Secretary under section 
                353 of the Public Health Service Act; and
                    ``(B) assembles for use solely within that 
                laboratory, without otherwise developing, an in vitro 
                clinical test appropriately listed in the comprehensive 
                test information system established under section 587T 
                by a different person.
            ``(8) First-of-a-kind.--The term `first-of-a-kind', with 
        respect to an in vitro clinical test, means that such test has 
        any novel combination of the elements specified in paragraph 
        (10) that differs from in vitro clinical tests that already are 
        legally available in the United States, except for such tests 
        offered under section 587C(a)(3), 587C(a)(4), or 587G.
            ``(9) High-risk.--The term `high-risk', with respect to an 
        in vitro clinical test or category of in vitro clinical tests, 
        means that an undetected inaccurate result from such test, or 
        such category of tests, when used as intended--
                    ``(A)(i) is reasonably likely to result in serious 
                or irreversible harm or death to a patient or patients, 
                or would otherwise cause serious harm to the public 
                health; or
                    ``(ii) is reasonably likely to result in the 
                absence, significant delay, or discontinuation of life-
                supporting or life-sustaining medical treatment; and
                    ``(B) mitigating measures are not able to be 
                established and applied to prevent, mitigate, or detect 
                the inaccurate result, or otherwise sufficiently 
                mitigate the risk resulting from an undetected 
                inaccurate result described in subparagraph (A), such 
                that the test would be moderate-risk or low-risk.
            ``(10) Indications for use.--The term `indications for 
        use', with respect to an in vitro clinical test, means the 
        following elements:
                    ``(A) Substance or substances measured by the in 
                vitro clinical test, such as an analyte, protein, or 
                pathogen.
                    ``(B) Test method.
                    ``(C) Test purpose or purposes, as described in 
                section 201(ss)(1).
                    ``(D) Diseases or conditions for which the in vitro 
                clinical test is intended for use, including intended 
                patient populations.
                    ``(E) Context of use, such as in a clinical 
                laboratory, in a health care facility, prescription 
                home use, over-the-counter use, or direct-to-consumer 
                testing.
            ``(11) Instrument.--
                    ``(A) In general.--The term `instrument' means an 
                analytical or pre-analytical instrument.
                    ``(B) Analytic instrument.--The term `analytic 
                instrument' means an in vitro clinical test that is 
                hardware intended by the developer to be used with one 
                or more other in vitro clinical tests to generate a 
                clinical test result, including software used to 
                effectuate the functionality of the hardware.
                    ``(C) Pre-analytical instrument.--The term `pre-
                analytical instrument' means an in vitro clinical test 
                that is hardware intended by the developer solely to 
                generate an output for use exclusively with one or more 
                analytical instruments as defined in subparagraph (B) 
                and which does not itself generate a clinical test 
                result. Such term may include software used to 
                effectuate the hardware's functionality.
            ``(12) Instrument family.--The term `instrument family' 
        means more than one instrument developed by the same developer 
        for which the developer demonstrates and documents, with 
        respect to all such instruments, that all--
                    ``(A) have the same basic architecture, design, and 
                performance characteristics;
                    ``(B) have the same indications for use and 
                capabilities;
                    ``(C) share the same measurement principles, 
                detection methods, and reaction conditions, as 
                applicable; and
                    ``(D) produce the same or similar analytical 
                results from samples of the same specimen type or 
                types.
            ``(13) Laboratory operations.--The term `laboratory 
        operations'--
                    ``(A) means the conduct of a laboratory examination 
                or other laboratory procedure on materials derived from 
                the human body, including the conduct of an in vitro 
                clinical test and associated activities, that is--
                            ``(i) regulated under section 353 of the 
                        Public Health Service Act; and
                            ``(ii) not related to the design, 
                        analytical validation, or clinical validation 
                        of an in vitro clinical test; and
                    ``(B) includes--
                            ``(i) performing pre-analytical and post-
                        analytical processes for an in vitro clinical 
                        test;
                            ``(ii) standard operating procedures and 
                        the conduct thereof; and
                            ``(iii) preparing reagents or other test 
                        materials that do not meet the criteria for 
                        being an in vitro clinical test for clinical 
                        use.
            ``(14) Low-risk.--The term `low-risk', with respect to an 
        in vitro clinical test or category of in vitro clinical tests, 
        means that an undetected inaccurate result from such in vitro 
        clinical test, or such category of in vitro clinical tests, 
        when used as intended--
                    ``(A) would cause only minimal or immediately 
                reversible harm, and would lead to only a remote risk 
                of adverse patient impact or adverse public health 
                impact; or
                    ``(B) sufficient mitigating measures are able to be 
                established and applied such that the in vitro clinical 
                test meets the standard described in subparagraph (A).
            ``(15) Mitigating measures.--The term `mitigating 
        measures'--
                    ``(A) means controls, standards, and other 
                requirements that the Secretary determines, based on 
                evidence, are necessary--
                            ``(i) for an in vitro clinical test, or a 
                        category of in vitro clinical tests, to meet 
                        the applicable standard; or
                            ``(ii) to mitigate the risk of harm ensuing 
                        from an undetected inaccurate result or 
                        misinterpretation of a result; and
                    ``(B) may include, as required by the Secretary, as 
                appropriate, applicable requirements regarding 
                labeling, conformance to performance standards and 
                consensus standards, performance testing, submission of 
                clinical data, advertising, website posting of 
                information, clinical studies, postmarket surveillance, 
                user comprehension studies, training, and confirmatory 
                laboratory, clinical findings, the history of the 
                developer, the role of a health professional in the 
                testing process, such as integration of the testing 
                laboratory into the direct medical care of the patient, 
                including direct interaction between the testing 
                laboratory and treating physician, or testing.
            ``(16) Moderate-risk.--The term `moderate-risk', with 
        respect to an in vitro clinical test or category of in vitro 
        clinical tests--
                    ``(A) means a test or category of tests that is not 
                high-risk under the criteria under paragraph (9) or 
                low-risk under the criteria under paragraph (14); and
                    ``(B) may include a test or category of tests that, 
                when used as intended, meet the criteria specified in 
                paragraph (9)(A) for high-risk, but for which one or 
                more mitigating measures are able to be established and 
                applied to prevent, mitigate, or detect an inaccurate 
                result or otherwise sufficiently mitigate the risk 
                resulting from an undetected inaccurate result, but are 
                not sufficient such that the test is low-risk under the 
                criteria in paragraph (14).
            ``(17) Specimen receptacle.--The term `specimen receptacle' 
        means an in vitro clinical test intended for taking, 
        collecting, holding, storing, or transporting of specimens 
        derived from the human body or for preparation, analysis, or in 
        vitro clinical examination for purposes described in section 
        201(ss)(1).
            ``(18) Technology.--The term `technology'--
                    ``(A) means a set of control mechanisms, energy 
                sources, or operating principles--
                            ``(i) that do not differ significantly 
                        among multiple in vitro clinical tests; and
                            ``(ii) for which design and development 
                        (including analytical and clinical validation, 
                        as applicable) of the tests would be addressed 
                        in a similar manner or through similar 
                        procedures; and
                    ``(B) may include clot detection, colorimetric 
                (non-immunoassay), electrochemical (non-immunoassay), 
                enzymatic (non-immunoassay), flow cytometry, 
                fluorometry (non-immunoassay), immunoassay, mass 
                spectrometry or chromatography, microbial culture, next 
                generation sequencing, nephlometric or turbidimetric 
                (non-immunoassay), singleplex or multiplex non-NGS 
                nucleic acid analysis, slide-based technology, 
                spectroscopy, and any other technology, as the 
                Secretary determines appropriate.
            ``(19) Test.--The term `test', unless otherwise provided, 
        means an in vitro clinical test.
            ``(20) Valid scientific evidence.--The term `valid 
        scientific evidence'--
                    ``(A) means, with respect to an in vitro clinical 
                test, evidence that--
                            ``(i) has been generated and evaluated by 
                        persons qualified by training or experience to 
                        do so, using procedures generally accepted by 
                        other persons so qualified; and
                            ``(ii) forms an appropriate basis for 
                        concluding by qualified experts whether the 
                        applicable standard has been met by the in 
                        vitro clinical test; and
                    ``(B) may include evidence described in 
                subparagraph (A) consisting of--
                            ``(i) peer-reviewed literature;
                            ``(ii) clinical guidelines;
                            ``(iii) reports of significant human 
                        experience with an in vitro clinical test;
                            ``(iv) bench studies;
                            ``(v) case studies or histories;
                            ``(vi) clinical data;
                            ``(vii) consensus standards;
                            ``(viii) reference standards;
                            ``(ix) data registries;
                            ``(x) postmarket data;
                            ``(xi) real world data;
                            ``(xii) clinical trials; and
                            ``(xiii) data collected in countries other 
                        than the United States if such data are 
                        demonstrated to be appropriate for the purpose 
                        of making a regulatory determination under this 
                        subchapter.

``SEC. 587A. REGULATION OF IN VITRO CLINICAL TESTS.

    ``(a) In General.--No person shall introduce or deliver for 
introduction into interstate commerce any in vitro clinical test, 
unless--
            ``(1) an approval of an application filed pursuant to 
        subsection (a) or (b) of section 587B is effective with respect 
        to such in vitro clinical test;
            ``(2) the in vitro clinical test is offered under a 
        technology certification order under section 587D(b)(1); or
            ``(3) the test is exempt under sections 587C or 587G from 
        the requirements of section 587B.
    ``(b) Transfer or Sale of In Vitro Clinical Tests.--
            ``(1) Transfer and assumption of regulatory obligations.--
        If ownership of an in vitro clinical test is sold or 
        transferred in such manner that the developer transfers the 
        regulatory submissions and obligations applicable under this 
        subchapter with respect to the test, the transferee or 
        purchaser becomes the developer of the test and shall have all 
        regulatory obligations applicable to such a test under this 
        subchapter. The transferee or purchaser shall update the 
        registration and listing information under section 587J for the 
        in vitro clinical test.
            ``(2) Transfer or sale of premarket approval.--
                    ``(A) Notice required.--If a developer of an in 
                vitro clinical test transfers or sells the approval of 
                the in vitro clinical test, the transferor or seller 
                shall--
                            ``(i) submit a notice of the transfer or 
                        sale to the Secretary and update the 
                        registration and listing information under 
                        section 587J for the in vitro clinical test; 
                        and
                            ``(ii) submit a supplement to an 
                        application if required under section 587B(h).
                    ``(B) Effective date of approval transfer.--A 
                transfer or sale described in subparagraph (A) shall 
                become effective upon completion of a transfer or sale 
                described in paragraph (1) or the approval of a 
                supplement to an application under section 587B(h) if 
                required, whichever is later. The transferee or 
                purchaser shall update the registration and listing 
                information under section 587J for the in vitro 
                clinical test within 15 calendar days of the effective 
                date of the transfer or sale.
            ``(3) Transfer or sale of technology certification.--
                    ``(A) Requirements for transfer or sale of 
                technology certification.--An unexpired technology 
                certification can be transferred or sold if the 
                transferee or purchaser--
                            ``(i) is an eligible person under section 
                        587D(a)(2); and
                            ``(ii) maintains, upon such transfer or 
                        sale, test design and quality requirements, 
                        processes and procedures under the scope of 
                        technology certification, and scope of the 
                        technology certification identified in the 
                        applicable technology certification order.
                    ``(B) Notice required.--If a developer of an in 
                vitro clinical test transfers or sells a technology 
                certification order that has not expired, the 
                transferor or seller shall submit a notice of the 
                transfer or sale to the Secretary and shall update the 
                registration and listing information under section 587J 
                for all in vitro clinical tests covered by the 
                technology certification.
                    ``(C) Effective date of technology certification 
                transfer.--The transfer of a technology certification 
                shall become effective upon completion of a transfer or 
                sale described in subparagraph (A). The transferee or 
                purchaser shall update the registration and listing 
                information under section 587J for the in vitro 
                clinical test within 30 calendar days of the effective 
                date of the technology certification transfer.
                    ``(D) New technology certification required.--If 
                the requirements of subparagraph (A)(ii) are not met, 
                the technology certification order may not be 
                transferred and the transferee or purchaser of an in 
                vitro clinical test is required to submit an 
                application for technology certification and obtain a 
                technology certification order prior to offering the 
                test for clinical use.
    ``(c) Regulations.--The Secretary may issue regulations to 
implement this subchapter.

``SEC. 587B. PREMARKET REVIEW.

    ``(a) Application.--
            ``(1) Filing.--Any developer may file with the Secretary an 
        application for premarket approval of an in vitro clinical test 
        under this subsection.
            ``(2) Transparency and predictability.--If a developer 
        files a premarket application under this section and provides 
        any additional documentation required under section 587D, the 
        in vitro clinical test that is the subject of the premarket 
        application may be utilized as the representative in vitro 
        clinical test reviewed by the Secretary to support a technology 
        certification order under section 587D.
            ``(3) Application content.--An application submitted under 
        paragraph (1) shall include the following, in such format as 
        the Secretary specifies:
                    ``(A) General information regarding the in vitro 
                clinical test, including--
                            ``(i) the name and address of the 
                        applicant;
                            ``(ii) the table of contents for the 
                        application and the identification of the 
                        information the applicant claims as trade 
                        secret or confidential commercial or financial 
                        information;
                            ``(iii) a description of the test's design 
                        and intended use, including the indications for 
                        use; and
                            ``(iv) a description regarding test 
                        function and performance characteristics.
                    ``(B) A summary of the data and information in the 
                application for the in vitro clinical test, including--
                            ``(i) a brief description of the foreign 
                        and domestic marketing history of the test, if 
                        any, including a list of all countries in which 
                        the test has been marketed and a list of all 
                        countries in which the test has been withdrawn 
                        from the market for any reason related to the 
                        ability of the in vitro clinical test to meet 
                        the applicable standard, if known by the 
                        applicant;
                            ``(ii) a description of benefit and risk 
                        considerations related to the in vitro clinical 
                        test, including a description of any applicable 
                        adverse effects of the test on health and how 
                        such adverse effects have been, or will be, 
                        mitigated;
                            ``(iii) a risk assessment of the test; and
                            ``(iv) a description of how the data and 
                        information in the application constitute valid 
                        scientific evidence and support a showing that 
                        the test meets the applicable standard under 
                        section 587(2).
                    ``(C) The signature of the developer filing the 
                premarket application or an authorized representative.
                    ``(D) A bibliography of applicable published 
                reports and a description of any studies conducted, 
                including any unpublished studies related to such test, 
                that are known or that should reasonably be known to 
                the applicant, and a description of data and 
                information relevant to the evaluation of whether the 
                test meets the applicable standard.
                    ``(E) Applicable information regarding the methods 
                used in, and the facilities or controls used for, the 
                development of the test to demonstrate compliance with 
                the applicable quality requirements under section 587K.
                    ``(F) Information demonstrating compliance with any 
                relevant and applicable--
                            ``(i) mitigating measures under section 
                        587E; and
                            ``(ii) standards established or recognized 
                        under section 514 prior to the date of 
                        enactment of the VALID Act of 2023, or, after 
                        applicable standards are established or 
                        recognized under section 587R, with such 
                        standards.
                    ``(G) Valid scientific evidence to support that the 
                test meets the applicable standard, which shall 
                include--
                            ``(i) summary information for all 
                        supporting validation studies performed, 
                        including a description of the objective of the 
                        study, a description of the experimental design 
                        of the study, a description of any limitations 
                        of the study, a brief description of how the 
                        data were collected and analyzed, a brief 
                        description of the results of each study, and 
                        conclusions drawn from each study;
                            ``(ii) raw data for each study, which may 
                        include, as applicable, tabulations of data and 
                        results; and
                            ``(iii) for nonclinical laboratory studies 
                        involving the test, if applicable, a statement 
                        that studies were conducted in compliance with 
                        applicable good laboratory practices.
                    ``(H) To the extent the application seeks 
                authorization to make modifications to the test within 
                the scope of the approval that are not otherwise 
                permitted without premarket review under this 
                subchapter, a proposed change protocol that includes 
                validation procedures and acceptance criteria for 
                anticipated modifications that could be made to the 
                test within the scope of the approval.
                    ``(I) Proposed labeling, in accordance with the 
                requirements of section 587L.
                    ``(J) Such other data or information as the 
                Secretary may require in accordance with the least 
                burdensome requirements under section 587AA(c).
            ``(4) Regulation for premarket and abbreviated premarket 
        applications.--Not later than 3 years after the date of 
        enactment of the VALID Act of 2023, the Secretary shall 
        promulgate final regulations detailing the information to be 
        provided in a premarket application and abbreviated premarket 
        application under this section.
            ``(5) Refuse to file a premarket or abbreviated premarket 
        application.--The Secretary may refuse to file an application 
        under this section only for lack of completeness or legibility 
        of the application. If, after receipt of an application under 
        this section, the Secretary refuses to file such an 
        application, the Secretary shall provide to the developer, 
        within 45 calendar days of receipt of such application 
        submitted under this subsection or within 30 calendar days of 
        receipt of an application submitted under subsection (b), a 
        description of the reason for such refusal, and identify the 
        information required, if any, to allow for the filing of the 
        application.
            ``(6) Substantive review for deficient application.--If, 
        after receipt of an application under this section, the 
        Secretary determines that any portion of such application is 
        materially deficient, the Secretary shall provide to the 
        applicant a description of such material deficiencies and the 
        information required to resolve such deficiencies.
            ``(7) Inspections.--With respect to an application under 
        paragraph (1), preapproval inspections authorized by an 
        employee of the Food and Drug Administration or a person 
        accredited under section 587Q need not occur unless requested 
        by the Secretary.
    ``(b) Abbreviated Premarket Review.--
            ``(1) In general.--Any developer may file with the 
        Secretary an application for abbreviated premarket approval 
        for--
                    ``(A) an instrument;
                    ``(B) a specimen receptacle;
                    ``(C) an in vitro clinical test that is moderate-
                risk; or
                    ``(D) an in vitro clinical test that is determined 
                by the Secretary to be eligible for abbreviated 
                premarket review under section 587F(a)(1)(B).
            ``(2) Application content.--An application under paragraph 
        (1) shall include--
                    ``(A) the information required for applications 
                submitted under subsection (a)(3), except that 
                applications under paragraph (1) need not include--
                            ``(i) quality requirement information; or
                            ``(ii) raw data, unless requested in 
                        writing by the Secretary, in accordance with 
                        the least burdensome requirements under section 
                        587AA(c), and with supervisory review and 
                        concurrence prior to issuance of such request; 
                        and
                    ``(B) data, as applicable, to support software 
                validation, electromagnetic compatibility, and 
                electrical safety, and information demonstrating 
                compliance with maintaining quality systems 
                documentation.
            ``(3) Safety information.--The developer of an in vitro 
        clinical test specimen receptacle reviewed under this 
        subsection shall maintain safety information for such specimen 
        receptacle.
            ``(4) Inspections.--With respect to an application under 
        paragraph (1), preapproval inspections shall not be required 
        unless requested in writing by the Secretary, after supervisory 
        review and concurrence, because such inspection is considered 
        necessary to complete the review.
    ``(c) Instruments and Instrument Families.--
            ``(1) In general.--A developer of an instrument family 
        shall file with the Secretary an application for premarket 
        approval of one version of an instrument under this subsection. 
        Any modified versions of the instrument that generate a new 
        instrument within the same instrument family shall be exempt 
        from premarket review requirements of this section, provided 
        that the developer of such instrument or instrument family--
                    ``(A) maintains documentation that the new 
                instrument is part of the instrument family, as defined 
                in section 587;
                    ``(B) performs, documents, and maintains a risk 
                assessment (as described in subsection (a)(3)(B)(iii)) 
                of the new instrument compared to the instrument 
                approved under subsection (b) and no new risks are 
                identified;
                    ``(C) performs, documents, and maintains validation 
                and verification activities for the new instrument;
                    ``(D) makes such documentation available to the 
                Secretary upon request; and
                    ``(E) registers and lists the new instrument in 
                accordance with section 587J.
            ``(2) Test kits and test protocols.--With regard to a test 
        kit or test protocol that is approved under this section for 
        use on an approved instrument or an instrument exempt from 
        premarket review, including an instrument within an instrument 
        family under this section, a submission under this section 
        shall not be required for such test kit or test protocol in 
        order for it to be used on a new instrument within its 
        instrument family, provided that--
                    ``(A) use of the test kit or test protocol with the 
                new instrument does not--
                            ``(i) change the claims for the test kit or 
                        test protocol, except as applicable, claims 
                        regarding an instrument or instruments that can 
                        be used with such test kit or test protocol;
                            ``(ii) adversely affect performance of the 
                        test kit or test protocol; or
                            ``(iii) cause the test kit or test protocol 
                        to no longer conform with performance standards 
                        required under section 587R or comply with any 
                        applicable mitigating measures under section 
                        587E, conditions of approval under subsection 
                        (e)(2)(B), or restrictions under section 587O;
                    ``(B) the test developer does not identify any new 
                risks for the test kit or test protocol when using the 
                new instrument after conducting a risk assessment;
                    ``(C) the test developer validates the use of the 
                new instrument with the test kit or test protocol and 
                maintains validation documentation;
                    ``(D) the test kit or test protocol is not intended 
                for use--
                            ``(i) in settings for which a certificate 
                        of waiver is in effect under section 353 of the 
                        Public Health Service Act;
                            ``(ii) without a prescription;
                            ``(iii) at home; or
                            ``(iv) in testing donors, donations, and 
                        recipients of blood, blood components, human 
                        cells, tissues, cellular-based products, or 
                        tissue-based products;
                    ``(E) the test developer makes the documentation 
                described under subparagraph (C) available to the 
                Secretary upon request; and
                    ``(F) the test developer updates the listing 
                information for the test kit or test protocol, as 
                applicable.
    ``(d) Amendments to an Application.--An applicant shall amend an 
application submitted under subsection (a), (b), or (f) if the 
applicant becomes aware of information that could reasonably affect an 
evaluation under subsection (e) of whether the approval standard has 
been met.
    ``(e) Action on an Application for Premarket Approval.--
            ``(1) Review.--
                    ``(A) Disposition.--As promptly as possible, but 
                not later than 90 calendar days after an application 
                under subsection (a) is accepted for submission (unless 
                the Secretary determines that an extension is necessary 
                to review one or more major amendments to the 
                application), or not later than 60 calendar days after 
                an application under subsection (b) is accepted for 
                submission or a supplemental application under 
                subsection (f) is accepted for submission, the 
                Secretary, after considering any applicable report and 
                recommendations pursuant to advisory committees under 
                section 587H, shall issue an order approving the 
                application, unless the Secretary finds that the 
                grounds for approval in paragraph (2) are not met.
                    ``(B) Reliance on proposed labeling.--In 
                determining whether to approve or deny an application 
                under paragraph (1), the Secretary shall rely on the 
                indications for use included in the proposed labeling, 
                provided that such labeling is not false or misleading 
                based on a fair evaluation of all material facts.
            ``(2) Approval of an application.--
                    ``(A) In general.--The Secretary shall approve an 
                application submitted under subsection (a) or (b) with 
                respect to an in vitro clinical test if the Secretary 
                finds that the applicable standard is met, and--
                            ``(i) the applicant is in compliance with 
                        applicable quality requirements in section 
                        587K;
                            ``(ii) the application does not contain a 
                        false statement or misrepresentation of 
                        material fact;
                            ``(iii) based on a fair evaluation of all 
                        material facts, the proposed labeling is 
                        truthful and non-misleading and complies with 
                        the requirements of section 587L;
                            ``(iv) the applicant permits, if requested, 
                        authorized employees of the Food and Drug 
                        Administration and persons accredited under 
                        section 587Q an opportunity to inspect pursuant 
                        to section 704;
                            ``(v) the test conforms with any applicable 
                        performance standards required under section 
                        587R and any applicable mitigating measures 
                        under section 587E;
                            ``(vi) all nonclinical laboratory studies 
                        and clinical investigations involving human 
                        subjects that are described in the application 
                        were conducted in a manner that meets the 
                        applicable requirements of this subchapter; and
                            ``(vii) other data and information the 
                        Secretary may require under subsection 
                        (a)(3)(J) support approval.
                    ``(B) Conditions of approval.--An order approving 
                an application pursuant to this section may require 
                reasonable conditions of approval for the in vitro 
                clinical test, which may include conformance with 
                applicable mitigating measures under section 587E, 
                restrictions under section 587O, and performance 
                standards under section 587R.
                    ``(C) Publication.--The Secretary shall publish an 
                order for each application approved pursuant to this 
                paragraph on the public website of the Food and Drug 
                Administration and make publicly available a summary of 
                the data used to approve such application. In making 
                the order and summary publicly available, the Secretary 
                shall not disclose any information that--
                            ``(i) is confidential commercial 
                        information or trade secret information subject 
                        to section 552(b)(4) of title 5, United States 
                        Code, or section 1905 of title 18, United 
                        States Code; or
                            ``(ii) could compromise national security.
            ``(3) Review of denials.--An applicant whose application 
        submitted under this section has been denied approval under 
        this subsection may, by petition filed not more than 60 
        calendar days after the date on which the applicant receives 
        notice of such denial, obtain review of the denial in 
        accordance with section 587P.
    ``(f) Supplements to an Approved Application.--
            ``(1) Risk analysis.--Prior to implementing any 
        modification to an in vitro clinical test, the holder of the 
        application approved under subsection (e) for such test shall 
        perform risk analyses in accordance with this subsection, 
        unless such modification is included in the change protocol 
        submitted by the applicant and approved under this section or 
        exempt under section 587C.
            ``(2) Supplement requirement.--
                    ``(A) In general.--If the holder of an application 
                of an approved in vitro clinical test makes a 
                modification to such in vitro clinical test, except as 
                provided in subparagraph (C), or otherwise specified by 
                the Secretary, the holder of the application approved 
                under subsection (e) for an in vitro clinical test 
                shall submit a supplemental application to the 
                Secretary. The holder of the application may not 
                implement such modification to the in vitro clinical 
                test until such supplemental application is approved. 
                The information required in a supplemental application 
                is limited to what is needed to support the change.
                    ``(B) Change protocols.--The holder of an approved 
                application may submit under this paragraph a 
                supplemental application to modify the change protocol 
                for a test or to request a change protocol for a test.
                    ``(C) Exceptions.--Notwithstanding subparagraphs 
                (A) and (B), and so long as the holder of an approved 
                application submitted under subsection (a) or (b) for 
                an in vitro clinical test does not add a manufacturing 
                site, or change activities at an existing manufacturing 
                site, with respect to the test, the holder of an 
                approved application may, without submission of a 
                supplemental application, implement the following 
                modifications to the test:
                            ``(i) Modifications in accordance with an 
                        approved change protocol under subsection 
                        (a)(3)(H).
                            ``(ii) Modifications that are exempt under 
                        section 587C(a)(6).
                            ``(iii) Labeling changes that are 
                        appropriate to address a safety concern, except 
                        such labeling changes that include any of the 
                        following remain subject to subparagraph (A):
                                    ``(I) A change to the indications 
                                for use of the test.
                                    ``(II) A change to the performance 
                                claims made with respect to the test.
                                    ``(III) A change that adversely 
                                affects performance of the test.
                    ``(D) Reporting for certain modifications made 
                pursuant to a change protocol.--The holder of an 
                application approved under subsection (e), with an 
                approved change protocol under subsection (a)(2)(H) for 
                such in vitro clinical test shall--
                            ``(i) report any modification to such test 
                        made pursuant to such change protocol approved 
                        under subsection (a)(3)(H) in a submission 
                        under section 587J(c)(2)(B); and
                            ``(ii) include in such report--
                                    ``(I) a description of the 
                                modification;
                                    ``(II) the rationale for 
                                implementing such modification; and
                                    ``(III) as applicable, a summary of 
                                the evidence supporting that the test, 
                                as modified, meets the applicable 
                                standard, complies with performance 
                                standards required under section 587Q, 
                                and complies with any mitigating 
                                measures established under section 587E 
                                and any restrictions under section 
                                587O.
                    ``(E) Reporting for certain safety related labeling 
                changes.--The holder of the application for an in vitro 
                clinical test approved under subsection (e) shall--
                            ``(i) report to the Secretary any 
                        modification to the test described in 
                        subparagraph (C)(iii) not more than 30 days 
                        after the date on which the test, with the 
                        modification, is introduced into interstate 
                        commerce; and
                            ``(ii) include in the report--
                                    ``(I) a description of the change 
                                or changes;
                                    ``(II) the rationale for 
                                implementing such change or changes; 
                                and
                                    ``(III) a description of how the 
                                change or changes were evaluated.
            ``(3) Contents of supplement.--Unless otherwise specified 
        by the Secretary, a supplement under this subsection shall 
        include--
                    ``(A) for modifications other than manufacturing 
                site changes requiring a supplement--
                            ``(i) a description of the modification;
                            ``(ii) data relevant to the modification to 
                        demonstrate that the applicable standard is 
                        met, not to exceed data requirements for the 
                        original submission;
                            ``(iii) acceptance criteria; and
                            ``(iv) any revised labeling; and
                    ``(B) for manufacturing site changes--
                            ``(i) the information listed in 
                        subparagraph (A); and
                            ``(ii) information regarding the methods 
                        used in, or the facilities or controls used 
                        for, the development of the test to demonstrate 
                        compliance with the applicable quality 
                        requirements under section 587K.
            ``(4) Additional data.--The Secretary may require, when 
        necessary, data to evaluate a modification to an in vitro 
        clinical test that is in addition to the data otherwise 
        required under the preceding paragraphs if the data request is 
        in accordance with the least burdensome requirements under 
        section 587AA(c).
            ``(5) Conditions of approval.--In an order approving a 
        supplement under this subsection, the Secretary may require 
        conditions of approval for the in vitro clinical test, 
        including compliance with restrictions under section 587O and 
        conformance to performance standards under section 587R.
            ``(6) Approval.--The Secretary shall approve a supplement 
        under this subsection if--
                    ``(A) the data demonstrate that the modified in 
                vitro clinical test meets the applicable standard; and
                    ``(B) the holder of the application approved under 
                subsection (e) for the test has demonstrated compliance 
                with applicable quality and inspection requirements, as 
                applicable and appropriate.
            ``(7) Publication.--The Secretary shall publish on the 
        public website of the Food and Drug Administration notice of 
        any order approving a supplement under this subsection provided 
        that doing so does not disclose any information that--
                    ``(A) is trade secret or confidential commercial or 
                financial information; or
                    ``(B) could compromise national security.
            ``(8) Review of denial.--An applicant whose supplement 
        under this subsection has been denied approval may, by petition 
        filed on or before the 60th calendar day after the date upon 
        which the applicant receives notice of such denial, obtain 
        review of the denial in accordance with section 587P.
    ``(g) Withdrawal and Temporary Suspension of Approval.--
            ``(1) Order withdrawing approval.--
                    ``(A) In general.--The Secretary may, after 
                providing due notice and an opportunity for an informal 
                hearing to the holder of an approved application for an 
                in vitro clinical test under this section, issue an 
                order withdrawing approval of the application if the 
                Secretary finds that--
                            ``(i) the grounds for approval under 
                        subsection (e) are no longer met;
                            ``(ii) there is a reasonable likelihood 
                        that the test would cause death or serious 
                        adverse health consequences, including by 
                        causing the absence, significant delay, or 
                        discontinuation of life-saving or life 
                        sustaining medical treatment;
                            ``(iii) the holder of the approved 
                        application--
                                    ``(I) has failed to, or repeatedly 
                                or deliberately failed to, maintain 
                                records to make reports, as required 
                                under section 587M;
                                    ``(II) has refused to permit access 
                                to, or copying or verification of such 
                                records, as required under section 704;
                                    ``(III) has not complied with the 
                                requirements of section 587K; or
                                    ``(IV) has not complied with any 
                                mitigating measure required under 
                                section 587E or restriction under 
                                section 587O; or
                            ``(iv) the labeling of such in vitro 
                        clinical test, based on a fair evaluation of 
                        all material facts, is false or misleading in 
                        any particular and was not corrected within a 
                        reasonable time after receipt of written notice 
                        from the Secretary of such fact.
                    ``(B) Content.--An order under subparagraph (A) 
                withdrawing approval of an application shall state each 
                ground for withdrawal and shall notify the holder of 
                such application 60 calendar days prior to issuing such 
                order.
                    ``(C) Publication.--The Secretary shall publish any 
                order under subparagraph (A) on the public website of 
                the Food and Drug Administration provided that doing so 
                does not disclose--
                            ``(i) any information that is trade secret 
                        or confidential commercial or financial 
                        information; or
                            ``(ii) any other information that the 
                        Secretary determines, if published, could 
                        compromise national security.
            ``(2) Order of temporary suspension.--If, after providing 
        due notice and an opportunity for an informal hearing to the 
        holder of an approved application for an in vitro clinical test 
        under this section, the Secretary determines, based on 
        scientific evidence, that there is a reasonable likelihood that 
        the in vitro clinical test would cause death or serious adverse 
        health consequences, such as by causing the absence, 
        significant delay, or discontinuation of life-saving or life-
        sustaining medical treatment, the Secretary shall, by order, 
        temporarily suspend the approval of the application. If the 
        Secretary issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw approval of such 
        application.
            ``(3) Appeal withdrawing approval and orders of temporary 
        suspensions.--An order of withdrawal or an order of temporary 
        suspension may be appealed under 587P.

``SEC. 587C. EXEMPTIONS.

    ``(a) In General.--The following in vitro clinical tests are exempt 
from premarket review under section 587B, and may be lawfully offered 
subject to other applicable requirements of this Act:
            ``(1) Tests exempt from section 510(k).--
                    ``(A) Exemption.--An in vitro clinical test is 
                exempt from premarket review under section 587B and may 
                be lawfully offered subject to the other applicable 
                requirements of this Act, if the developer of the in 
                vitro clinical test--
                            ``(i) maintains documentation demonstrating 
                        that the test meets and continues to meet the 
                        criteria set forth in subparagraph (B); and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
                    ``(B) Criteria for exemption.--An in vitro clinical 
                test is exempt as specified in subparagraph (A) if such 
                test--
                            ``(i)(I)(aa) was offered for clinical use 
                        prior to the date of enactment of the VALID Act 
                        of 2023; and
                            ``(bb) immediately prior to such date of 
                        enactment was exempt pursuant to subsection (l) 
                        or (m)(2) of section 510 from the requirements 
                        for submission of a report under section 
                        510(k); or
                            ``(II)(aa) was not offered for clinical use 
                        prior to such date of enactment;
                            ``(bb) is not an instrument; and
                            ``(cc) falls within a category of tests 
                        that was exempt from the requirements for 
                        submission of a report under section 510(k) as 
                        of such date of enactment (including class II 
                        devices and excluding class I devices described 
                        in section 510(l));
                            ``(ii) meets the applicable standard as 
                        described in section 587(2);
                            ``(iii) is not offered with labeling and 
                        advertising that is false or misleading; and
                            ``(iv) is not likely to cause or contribute 
                        to serious adverse health consequences.
                    ``(C) Effect on special controls.--For any in vitro 
                clinical test, or category of in vitro clinical tests, 
                that is exempt from premarket review based on the 
                criteria in subparagraph (B), any special control that 
                applied to a device within a predecessor category 
                immediately prior to the date of enactment of the VALID 
                Act of 2023 shall be deemed a mitigating measure 
                applicable under section 587E to an in vitro clinical 
                test within the successor category, except to the 
                extent such mitigating measure is withdrawn or changed 
                in accordance with section 587E.
                    ``(D) Near-patient testing.--Not later than 1 year 
                after the date of enactment of the VALID Act of 2023, 
                the Secretary shall issue draft guidance indicating 
                categories of tests that shall be exempt from premarket 
                review under section 587B when offered for near-patient 
                testing (point of care), which were not exempt from 
                submission of a report under section 510(k) pursuant to 
                subsection (l) or (m)(2) of section 510 and regulations 
                imposing limitations on exemption for in vitro devices 
                intended for near-patient testing (point of care).
            ``(2) Low-risk tests.--
                    ``(A) Exemption.--An in vitro clinical test is 
                exempt from premarket review under section 587B and may 
                be lawfully offered subject to the other applicable 
                requirements of this Act, including section 587J(b), if 
                such test meets the definition of low-risk under 
                section 587 and if the developer of the test--
                            ``(i) maintains documentation demonstrating 
                        that the in vitro clinical test meets and 
                        continues to meet the criteria set forth in 
                        subparagraph (B); and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
                    ``(B) Criteria for exemption.--An in vitro clinical 
                test is exempt as specified in subparagraph (A) if--
                            ``(i) the in vitro clinical test meets the 
                        applicable standard as described in 587(2);
                            ``(ii) the labeling and advertising are not 
                        false or misleading;
                            ``(iii) the in vitro clinical test is not 
                        likely to cause or contribute to serious 
                        adverse health consequences; and
                            ``(iv) the in vitro clinical test falls 
                        within a category of tests listed as described 
                        in subparagraph (C).
                    ``(C) List of low-risk tests.--
                            ``(i) In general.--The Secretary shall 
                        maintain, and make publicly available on the 
                        website of the Food and Drug Administration, a 
                        list of in vitro clinical tests, and categories 
                        of in vitro clinical tests, that are low-risk 
                        in vitro clinical tests for purposes of the 
                        exemption under this paragraph.
                            ``(ii) Inclusion.--The list under clause 
                        (i) shall consist of--
                                    ``(I) all in vitro clinical tests 
                                and categories of in vitro clinical 
                                tests that are exempt from premarket 
                                review pursuant to paragraph (1) or 
                                this paragraph; and
                                    ``(II) all in vitro clinical tests 
                                and categories of in vitro clinical 
                                tests that are designated by the 
                                Secretary pursuant to subparagraph (D) 
                                as low-risk for purposes of this 
                                paragraph.
                    ``(D) Designation of tests and categories.--Without 
                regard to subchapter II of chapter 5 of title 5, United 
                States Code, the Secretary may designate, in addition 
                to the tests and categories described in subparagraph 
                (C)(i), additional in vitro clinical tests, and 
                categories of in vitro clinical tests, as low-risk in 
                vitro clinical tests for purposes of the exemption 
                under this paragraph. The Secretary may make such a 
                designation on the Secretary's own initiative or in 
                response to a request by a developer pursuant to 
                subsection (a) or (b) of section 587F. In making such a 
                designation for a test or category of tests, the 
                Secretary shall consider--
                            ``(i) whether the test, or category of 
                        tests, is low-risk;
                            ``(ii) the existence of and ability to 
                        develop mitigating measures sufficient for such 
                        test category to meet the low-risk standard; 
                        and
                            ``(iii) such other factors as the Secretary 
                        determines to be appropriate for the protection 
                        of the public health.
            ``(3) Humanitarian test exemption.--
                    ``(A) In general.--An in vitro clinical test that 
                meets the criteria under subparagraph (B) is exempt 
                from premarket review under section 587B and may be 
                lawfully offered subject to the other applicable 
                requirements of this subchapter, if the developer of 
                the test--
                            ``(i) maintains documentation (which may 
                        include literature citations in specialized 
                        medical journals, textbooks, specialized 
                        medical society proceedings, and governmental 
                        statistics publications, or, if no such studies 
                        or literature citations exist, credible 
                        conclusions from appropriate research or 
                        surveys) demonstrating that such test meets and 
                        continues to meet the criteria described in 
                        this subsection; and
                            ``(ii) makes such documentation available 
                        to the Secretary upon request.
                    ``(B) Criteria for exemption.--An in vitro clinical 
                test is exempt as described in subparagraph (A) if--
                            ``(i) the in vitro clinical test is 
                        intended by the developer for use for a 
                        diagnostic purpose for--
                                    ``(I) a noncontagious disease or 
                                condition that affects not more than 
                                10,000 (or such other higher number 
                                determined by the Secretary) 
                                individuals in the United States per 
                                year; or
                                    ``(II) a contagious disease or 
                                condition that affects not more than 
                                1,500 individuals in the United States 
                                per year;
                            ``(ii) the in vitro clinical test meets the 
                        applicable standard described in section 
                        587(2);
                            ``(iii) the labeling and advertising for 
                        the in vitro clinical test are not false or 
                        misleading;
                            ``(iv) the in vitro clinical test is not 
                        likely to cause or contribute to serious 
                        adverse health consequences; and
                            ``(v) the in vitro clinical test is not 
                        intended for screening.
                    ``(C) Exception for certain tests.--An in vitro 
                clinical test intended to inform the use of a specific 
                individual or specific type of biological product, 
                drug, or device shall be eligible for an exemption from 
                premarket review under this subsection only if, the 
                developer submits a request under section 587F(e) for 
                informal feedback and the Secretary determines that 
                such in vitro clinical test is eligible for an 
                exemption from premarket review under this subsection.
            ``(4) Custom tests and low-volume tests.--An in vitro 
        clinical test is exempt from premarket review under section 
        587B, quality requirements under section 587K, and listing 
        requirements under section 587J, and may be lawfully offered 
        subject to the other applicable requirements of this Act, if--
                    ``(A) such in vitro clinical test--
                            ``(i) is a test protocol performed for not 
                        more than 5 patients per year (or such other 
                        higher number determined by the Secretary), in 
                        a laboratory certified by the Secretary under 
                        section 353 of the Public Health Service Act 
                        that--
                                    ``(I) meets the requirements to 
                                perform tests of high-complexity in 
                                which the test protocol was developed; 
                                or
                                    ``(II) meets the requirements to 
                                perform tests of high-complexity within 
                                the same corporate organization and 
                                having common ownership by the same 
                                parent corporation as the laboratory in 
                                which such test protocol was developed; 
                                or
                            ``(ii) is an in vitro clinical test 
                        developed to diagnose a unique pathology or 
                        physical condition of a specific patient or 
                        patients (including an in vitro clinical test 
                        modified for such purpose), upon the 
                        prescription or order of a health care 
                        practitioner licensed to prescribe or order 
                        such test, or a health care professional or 
                        other specially qualified person designated 
                        under regulations to prescribe or order such 
                        test, for which no other in vitro clinical test 
                        is commercially available in the United States, 
                        and is--
                                    ``(I) not intended for use with 
                                respect to more than 5 (or such other 
                                higher number determined by the 
                                Secretary) other patients; and
                                    ``(II) not included in any test 
                                menu or template test report or other 
                                promotional materials, and is not 
                                otherwise advertised; and
                    ``(B) the developer of the in vitro clinical test--
                            ``(i) maintains documentation demonstrating 
                        that such test meets the applicable criteria 
                        described in subparagraph (A);
                            ``(ii) makes such documentation, such as a 
                        prescription order requesting the custom test 
                        for an individual patient, available to the 
                        Secretary upon request; and
                            ``(iii) informs the Secretary, on an annual 
                        basis, in a manner prescribed by the Secretary 
                        by guidance, that such test was offered.
            ``(5) In vitro clinical tests under a technology 
        certification order.--An in vitro clinical test that is within 
        the scope of a technology certification order under section 
        587D is exempt from premarket review under section 587B.
            ``(6) Modified tests.--
                    ``(A) In general.--An in vitro clinical test that 
                is modified is exempt from premarket review under 
                section 587B if--
                            ``(i) the modification is made by--
                                    ``(I) the developer that obtained 
                                premarket approval for the unmodified 
                                version of the test under section 587B; 
                                or
                                    ``(II) a clinical laboratory 
                                certified by the Secretary under 
                                section 353 of the Public Health 
                                Service Act that meets the requirements 
                                for performing high complexity testing, 
                                to a lawfully offered in vitro clinical 
                                test, including another developer's 
                                lawfully offered in vitro clinical 
                                test, excluding investigational in 
                                vitro clinical tests offered under 
                                section 587S, and the modified test is 
                                performed--
                                            ``(aa) in the same clinical 
                                        laboratory in which it was 
                                        developed for which a 
                                        certification is still in 
                                        effect under section 353 that 
                                        meets the requirements to 
                                        perform tests of high 
                                        complexity;
                                            ``(bb) by another clinical 
                                        laboratory for which a 
                                        certificate is in effect under 
                                        section 353 that meets the 
                                        requirements to perform tests 
                                        of high complexity, is within 
                                        the same corporate 
                                        organization, and has common 
                                        ownership by the same parent 
                                        corporation as the laboratory 
                                        in which the test was 
                                        developed; or
                                            ``(cc) by a clinical 
                                        laboratory for which a 
                                        certificate is in effect under 
                                        section 353 that meets the 
                                        requirements to perform tests 
                                        of high complexity and is 
                                        within a public health 
                                        laboratory network coordinated 
                                        or managed by the Centers for 
                                        Disease Control and Prevention, 
                                        if the test was developed by 
                                        the Centers for Disease Control 
                                        and Prevention or another 
                                        laboratory within such public 
                                        health laboratory network;
                            ``(ii) the modification does not--
                                    ``(I) constitute a significant 
                                change to the indications for use, 
                                except for changes to a specimen type, 
                                as specified in the guidance issued 
                                under subparagraph (E);
                                    ``(II) cause the test to no longer 
                                comply with applicable mitigating 
                                measures under section 587E or 
                                restrictions under section 587O;
                                    ``(III) significantly change 
                                performance claims or significantly and 
                                adversely change performance, unless 
                                provided for under an approved change 
                                protocol under section 587B(a)(3)(H); 
                                or
                                    ``(IV) constitute an adverse change 
                                in the safety of the in vitro clinical 
                                test for individuals who come in 
                                contact with the in vitro clinical 
                                test;
                            ``(iii) the test meets the applicable 
                        standard as described in section 587(2);
                            ``(iv) the labeling and advertising are not 
                        false or misleading; and
                            ``(v) the test is not likely to cause or 
                        contribute to serious adverse health 
                        consequences.
                    ``(B) Certain modifications.--A modification to 
                extend specimen stability is exempt from premarket 
                review under section 587B if the modified test meets 
                the requirements in clauses (ii) through (v) of 
                subparagraph (A).
                    ``(C) Modifications under a change protocol.--
                Notwithstanding subparagraph (A), a modification made 
                under a change protocol pursuant to subsection 
                (a)(2)(H) of section 587B is exempt from review under 
                such section.
                    ``(D) Documentation.--A person who modifies an in 
                vitro clinical test in a manner that is a modification 
                described in this paragraph shall--
                            ``(i) document the modification that was 
                        made and the basis for determining that the 
                        modification, considering the changes 
                        individually and collectively, is a type of 
                        modification described in subparagraph (A), 
                        (B), or (C); and
                            ``(ii) provide such documentation to the 
                        Secretary upon request or inspection.
                    ``(E) Guidance.--Not later than 30 months after the 
                date of enactment of the VALID Act of 2023, the 
                Secretary shall issue guidance regarding the in vitro 
                clinical tests that are modified and exempt from 
                premarket review under section 587B pursuant to this 
                paragraph. Such guidance shall include considerations 
                for changes to a specimen type that may be made by a 
                developer without the requirement of premarket review 
                under 587B.
    ``(b) Manual Tests.--
            ``(1) Exemption.--An in vitro clinical test is exempt from 
        all requirements of this subchapter if the output of such in 
        vitro clinical test is the result of direct, manual 
        observation, without the use of automated instrumentation or 
        software for intermediate or final interpretation, by a 
        qualified laboratory professional, and such in vitro clinical 
        test--
                    ``(A) is developed and used within a single 
                clinical laboratory for which a certificate is in 
                effect under section 353 of the Public Health Service 
                Act that meets the requirements under section 353 for 
                performing high-complexity testing;
                    ``(B) is not a specimen receptacle, instrument, or 
                an in vitro clinical test that includes an instrument 
                or specimen receptacle that is not approved under or 
                exempt from section 587B;
                    ``(C) is not a high-risk test, or is a high-risk 
                test that the Secretary has determined meets at least 
                one condition in paragraph (2) and is otherwise 
                appropriate for this exemption; and
                    ``(D) is not intended for testing donors, 
                donations, or recipients of blood, blood components, 
                human cells, tissues, cellular-based products, or 
                tissue-based products.
            ``(2) High-risk test limitation or condition.--A high-risk 
        test may be exempt under paragraph (1) from the requirements of 
        this subchapter only if--
                    ``(A) no components or parts of such test, 
                including any reagent, is introduced into interstate 
                commerce under the exemption under subsection (e), and 
                any article for taking or deriving specimens from the 
                human body used in conjunction with the test remains 
                subject to the requirements of this subchapter; or
                    ``(B) the test has been developed in accordance 
                with the applicable test design and quality 
                requirements under section 587K.
    ``(c) Public Health Surveillance Activities.--
            ``(1) In general.--The provisions of this subchapter shall 
        not apply to a test intended by the developer to be used solely 
        for public health surveillance activities.
            ``(2) Exclusion.--An in vitro clinical test used for public 
        health surveillance activities is not excluded from the 
        provisions of this subchapter pursuant to this subsection if 
        such test is intended for use in making clinical decisions for 
        individual patients. 
    ``(d) General Laboratory Equipment.--As set forth in section 
201(ss)(3)(C), general purposes laboratory equipment is not an in vitro 
clinical tests and is not subject to the requirements of this 
subchapter.
    ``(e) Components and Parts.--
            ``(1) In general.--Subject to paragraph (2), a component or 
        part described in section 201(ss)(2)(G) is--
                    ``(A) exempt from the requirements of this 
                subchapter if it is intended for further development as 
                described in paragraph (3); or
                    ``(B) subject to the requirements of this 
                subchapter and regulated based on its risk when used as 
                intended by the developer, notwithstanding its 
                subsequent use by a developer as a component, part, or 
                raw material of another in vitro clinical test.
            ``(2) Inapplicability to other tests.--Notwithstanding 
        paragraph (1), an in vitro clinical test that is described in 
        section 201(ss)(1)(B) and that uses a component or part 
        described in such subparagraph shall be subject to the 
        requirements of this subchapter, unless the test is otherwise 
        exempt under this section.
            ``(3) Further development.--A component, part, or raw 
        material (as described in paragraph (1)) is intended for 
        further development (for purposes of such paragraph) if--
                    ``(A) it is intended solely for use in the 
                development of another in vitro clinical test; and
                    ``(B) in the case of such a test that is introduced 
                or delivered for introduction into interstate commerce 
                after the date of enactment of the VALID Act of 2023, 
                the labeling of such test bears the following 
                statement: `This product is intended solely for further 
                development of an in vitro clinical test and is exempt 
                from FDA regulation. This product must be evaluated by 
                the in vitro clinical test developer if it is used with 
                or in the development of an in vitro clinical test.'.
    ``(f) General Exemption Authority.--The Secretary may, by order 
published in the Federal Register following notice and an opportunity 
for comment, exempt a class of persons from any section under this 
subchapter upon a finding that such exemption is appropriate for the 
protection of the public health and other relevant considerations.
    ``(g) Other Exemptions.--An in vitro clinical test that is intended 
solely for use in forensic analysis or law enforcement activity is 
exempt from the requirements of this subchapter. An in vitro clinical 
test that is intended for use in making clinical decisions for 
individual patients, or whose individually identifiable results may be 
reported back to an individual patient or the patient's health care 
provider, even if also intended for forensic analysis or law 
enforcement purposes, is not intended solely for forensic analysis or 
law enforcement for purposes of this subsection.
    ``(h) Revocation.--
            ``(1) In general.--The Secretary may revoke any exemption 
        under this section with respect to in vitro clinical tests with 
        the same indications for use if new clinical information 
        indicates that the exemption of an in vitro clinical test or 
        tests from premarket review under section 587B has a reasonable 
        probability of severe adverse health consequences, including 
        the absence, delay, or discontinuation of appropriate medical 
        treatment.
            ``(2) Process.--Any action under paragraph (1) shall be 
        made by publication of a notice of such proposed action on the 
        website of the Food and Drug Administration, the consideration 
        of comments to a public docket on such proposal, and 
        publication of a final action on such website within 60 
        calendar days of the close of the comment period posted to such 
        public docket, notwithstanding subchapter II of chapter 5 of 
        title 5, United States Code.
    ``(i) Pre-Analytical Instrument.--A pre-analytical instrument is 
exempt from premarket review under section 587B and may be lawfully 
offered subject to the other applicable requirements of this Act, if 
either of the following applies:
            ``(1) Such instrument provides additional information 
        regarding the sample or performs an action on the sample but is 
        not preparing or processing the sample and does not perform any 
        function of an analytical instrument. Such types of pre-
        analytical instruments include barcode readers, sample movers, 
        and sample identifiers.
            ``(2) Such instrument processes or prepares the sample 
        prior to use on an analytical instrument, does not perform any 
        function of an analytical instrument, and does not select, 
        isolate, or prepare a part of a sample based on specific 
        properties. Such types of pre-analytical instruments may 
        include sample mixers, DNA extractors and those used to dilute 
        samples.

``SEC. 587D. TECHNOLOGY CERTIFICATION.

    ``(a) Definitions.--In this section:
            ``(1) Eligible in vitro clinical test.--The term `eligible 
        in vitro clinical test' means an in vitro clinical test that is 
        not--
                    ``(A) a component or part of an in vitro clinical 
                test as described in section 201(ss)(2)(G) unless it is 
                a component or part and is regulated based on its own 
                risk under section 587C(e)(1)(B) or as part of an 
                otherwise eligible in vitro clinical test;
                    ``(B) an instrument under section 201(ss)(2)(D) or 
                an in vitro clinical test that includes an instrument 
                that is subject to section 587B, but is not approved 
                under, or exempt from, section 587B;
                    ``(C) a specimen receptacle under section 
                201(ss)(2)(E) or an in vitro clinical test that 
                includes a specimen receptacle that is subject to 
                section 587B, but is not approved under, or exempt 
                from, section 587B;
                    ``(D) an in vitro clinical test, including reagents 
                used in such tests, intended for use for testing 
                donors, donations, and recipients of blood, blood 
                components, human cells, tissues, cellular-based 
                products, or tissue-based products;
                    ``(E) high-risk;
                    ``(F) a combination product, unless such test has 
                been determined to be eligible to be introduced into 
                interstate commerce under a technology certification 
                order pursuant to the regulatory pathway designation 
                process described in section 587F, or as described in 
                subsection (k), and the drug or biological product 
                constituent part complies with the requirements of 
                section 503(g) applicable to the drug or biological 
                product; or
                    ``(G) a first-of-a-kind in vitro clinical test, 
                unless such test has been determined to be eligible to 
                be introduced into interstate commerce under a 
                technology certification order pursuant to the 
                regulatory pathway designation process described in 
                section 587F, or as described in subsection (k).
            ``(2) Eligible person.--The term `eligible person' means an 
        in vitro clinical test developer unless such developer--
                    ``(A) is a laboratory subject to section 353 of the 
                Public Health Service Act and does not have in effect a 
                certificate applicable to the category of laboratory 
                examination or other procedure;
                    ``(B) was a laboratory, or an owner or operator or 
                any employee of a laboratory, found to have committed a 
                significant violation of section 353 of the Public 
                Health Service Act that resulted in a suspended, 
                revoked, or limited certificate within the 2-year 
                period preceding the date of the submission of the 
                application for a technology certificate under 
                subsection (c) and such violation has not been 
                resolved; or
                    ``(C) has been found to have submitted information 
                to the Secretary, or otherwise disseminated 
                information, that--
                            ``(i) made false or misleading statements 
                        relevant to the requirements of this 
                        subchapter; or
                            ``(ii) violated any requirement of this 
                        Act, where such violation exposed individuals 
                        to serious risk of illness, injury, or death, 
                        unless--
                                    ``(I) such violation has been 
                                resolved; or
                                    ``(II) such violation is not 
                                pertinent to any in vitro clinical test 
                                within the scope of the technology 
                                certification that such developer 
                                seeks.
    ``(b) Applicability.--
            ``(1) In general.--An in vitro clinical test is not subject 
        to section 587B and may be introduced into interstate commerce 
        if the in vitro clinical test--
                    ``(A) is an eligible in vitro clinical test;
                    ``(B) is developed by an eligible person;
                    ``(C) falls within the scope of a technology 
                certification order issued under this section and that 
                is in effect;
                    ``(D) complies with the conditions of the 
                technology certification order, including with 
                applicable mitigating measures under section 587E, 
                restrictions under section 587O, and performance 
                standards under section 587R; and
                    ``(E) meets the applicable standard described in 
                section 587(2).
            ``(2) Scope.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                scope of a technology certification order issued under 
                this section shall apply to one or more technologies 
                with multiple in vitro clinical tests utilizing a 
                technology that does not significantly differ in 
                control mechanisms, energy sources, or operating 
                principles and for which development, including design, 
                and analytical and clinical validation, of the in vitro 
                clinical tests would be addressed through similar 
                procedures, and be no broader than--
                            ``(i) a single technology type; or
                            ``(ii) a fixed combination of technologies.
                    ``(B) Technology type.--A technology type described 
                in this paragraph may include clot detection, 
                colorimetric (non-immunoassay), electrochemical (non-
                immunoassay), enzymatic (non-immunoassay), flow 
                cytometry, fluorometry (non-immunoassay), immunoassay, 
                mass spectrometry or chromatography, microbial culture, 
                next generation sequencing, nephlometric or 
                turbidimetric (non-immunoassay), singleplex or 
                multiplex non-NGS nucleic acid analysis, slide-based 
                technology, spectroscopy, and any other technology, as 
                the Secretary determines appropriate.
    ``(c) Application for Technology Certification.--
            ``(1) In general.--A developer seeking a technology 
        certification order shall submit an application under this 
        subsection, which shall contain the information specified under 
        paragraph (2).
            ``(2) Content of application.--A developer that submits an 
        application for a technology certification shall include all 
        necessary information to make a showing that all eligible in 
        vitro clinical tests developed within the scope of the 
        technology certification order will meet the applicable 
        standard, including--
                    ``(A) the name and address of the developer;
                    ``(B) a table of contents for the application and 
                the identification of the information the developer 
                claims as trade secret or confidential commercial or 
                financial information;
                    ``(C) the signature of the individual filing the 
                application or an authorized representative;
                    ``(D) a statement identifying the scope of the 
                proposed technology certification intended to be 
                introduced into interstate commerce under the 
                application;
                    ``(E) information establishing that the developer 
                submitting the application is an eligible person;
                    ``(F) quality procedures showing that eligible in 
                vitro clinical tests covered under the technology 
                certification will conform to the applicable quality 
                requirements of section 587K with respect to--
                            ``(i) design controls, including related 
                        purchasing controls and acceptance activities;
                            ``(ii) complaint investigation, adverse 
                        event reporting, and corrections and removals; 
                        and
                            ``(iii) process validation, as applicable;
                    ``(G) procedures for analytical and clinical 
                validation, including all procedures for validation, 
                verification, and acceptance criteria, and an 
                explanation as to how such procedures, when used, 
                provide a showing that eligible in vitro clinical tests 
                within the proposed scope of the technology 
                certification order are analytically and clinically 
                valid;
                    ``(H) procedures that provide a showing that in 
                vitro clinical tests covered by the proposed scope of 
                the technology certification order will be safe for 
                individuals who come into contact with in vitro 
                clinical tests covered by such order;
                    ``(I) a proposed listing submission under section 
                587J(b) for in vitro clinical tests that the developer 
                intends to introduce into interstate commerce upon 
                receiving a technology certification order, which shall 
                not be construed to limit the developer from 
                introducing additional tests not included in such 
                submission under the same technology certification 
                order;
                    ``(J) information concerning one or more 
                representative in vitro clinical tests, including--
                            ``(i) a test within the scope of the 
                        technology certification application with the 
                        appropriate analytical complexity at the time 
                        of the submission of the application under this 
                        section to serve as the representative test;
                            ``(ii) the information specified in 
                        subsection (a) or (b) of section 587B, as 
                        applicable, for the representative in vitro 
                        clinical test or tests, unless the Secretary 
                        determines that such information is not 
                        necessary;
                            ``(iii) a summary of a risk assessment of 
                        the in vitro clinical test;
                            ``(iv) an explanation of the choice of the 
                        representative in vitro clinical test or tests 
                        for the technology certification application 
                        and how such test adequately demonstrates the 
                        range of procedures that the developer includes 
                        in the application under subparagraphs (F), 
                        (G), (H), and (I); and
                            ``(v) a brief explanation of the ways in 
                        which the procedures included in the 
                        application under subparagraphs (F), (G), (H), 
                        and (I) have been applied to the representative 
                        in vitro clinical test or tests; and
                    ``(K) such other information necessary to make a 
                determination on a technology certification application 
                as the Secretary may determine necessary.
            ``(3) Reference to existing applications.--With respect to 
        the content requirements in the technology certification 
        application described in paragraph (2), a developer may 
        incorporate by reference any content of an application 
        previously submitted by the developer.
    ``(d) Action on an Application for Technology Certification.--
            ``(1) Secretary response.--
                    ``(A) In general.--As promptly as practicable, and 
                not later than 90 days after receipt of an application 
                under subsection (c), the Secretary shall--
                            ``(i) if the Secretary finds that all of 
                        the grounds in paragraph (3) are met, issue a 
                        technology certification order granting the 
                        application, which--
                                    ``(I) may include reasonable 
                                conditions of certification; and
                                    ``(II) shall specify the scope of 
                                the technology certification; or
                            ``(ii) deny the application, if the 
                        Secretary finds (and sets forth the basis of 
                        such finding as part of or accompanying such 
                        denial) that one or more grounds for granting 
                        the application specified in paragraph (3) are 
                        not met.
                    ``(B) Extension.--The timeline described in 
                subparagraph (A) may be extended by mutual agreement 
                between the Secretary and the applicant.
            ``(2) Deficient applications.--
                    ``(A) In general.--If, after receipt of an 
                application under this section, the Secretary 
                determines that any portion of such application is 
                deficient, the Secretary, not later than 60 days after 
                receipt of such application, shall provide to the 
                applicant a description of such deficiencies and 
                identify the information required to resolve such 
                deficiencies.
                    ``(B) Converting to premarket applications.--When 
                responding to the deficiency letter, the developer may 
                convert the application for technology certification 
                under subsection (c) into a premarket application under 
                section 587B.
            ``(3) Technology certification order.--The Secretary shall 
        issue an order granting a technology certification under this 
        section if, on the basis of the information submitted to the 
        Secretary as part of the application and any other information 
        with respect to such applicant, the Secretary finds that--
                    ``(A) there is a showing that in vitro clinical 
                tests within the scope of the technology certification 
                order will meet the applicable standard;
                    ``(B) the methods used in, and the facilities or 
                controls used for, the development of eligible in vitro 
                clinical tests covered by the proposed scope of the 
                technology certification conform to the applicable 
                requirements of section 587K with respect to--
                            ``(i) design controls, including related 
                        purchasing controls and acceptance activities;
                            ``(ii) complaint investigation, adverse 
                        event reporting, and corrections and removals; 
                        and
                            ``(iii) process validation, as applicable;
                    ``(C) based on a fair evaluation of all material 
                facts, the applicant's proposed labeling and 
                advertising are not false or misleading in any 
                particular;
                    ``(D) the application does not contain a false 
                statement of material fact;
                    ``(E) there is a showing that the representative in 
                vitro clinical test or tests--
                            ``(i) meet the applicable standard; and
                            ``(ii) reasonably represent the range of 
                        procedures required to be submitted in the 
                        application;
                    ``(F) the applicant has agreed to permit, upon 
                request, authorized employees of the Food and Drug 
                Administration or persons accredited, or recognized 
                under this Act, an opportunity to inspect at a 
                reasonable time and in a reasonable manner the 
                facilities and all pertinent equipment, finished and 
                unfinished materials, containers, and labeling therein, 
                including all things (including records, files, papers, 
                and controls) bearing on whether an in vitro clinical 
                test is adulterated, misbranded, or otherwise in 
                violation of this Act, and permits such authorized 
                employees or persons accredited under this Act to view 
                and to copy and verify all records pertinent to the 
                application and the in vitro clinical test; and
                    ``(G) based on other data and information the 
                Secretary may require under subsection (c)(2)(K), the 
                Secretary finds that such data and information support 
                granting a technology certification order.
            ``(4) Review of denials.--An applicant whose application 
        has been denied under this subsection may obtain review of such 
        denial under section 587P.
    ``(e) Supplements.--
            ``(1) Supplemental applications.--
                    ``(A) In general.--With respect to any of the 
                following changes related to a technology certification 
                order, a supplemental application to a technology 
                certification order shall be submitted by the holder of 
                the technology certification order describing such 
                proposed changes, and the in vitro clinical test with 
                such changes may not be introduced into interstate 
                commerce until a technology certification order for 
                such supplemental application is granted:
                            ``(i) Any significant change to the 
                        procedures provided in support of the 
                        application for technology certification 
                        submitted under subparagraph (G) or (H) of 
                        subsection (c)(2).
                            ``(ii) Any significant change to the 
                        procedures provided in support of the 
                        application for technology certification 
                        submitted under subparagraph (F) of subsection 
                        (c)(2).
                    ``(B) Secretary action on supplemental 
                applications.--Any action by the Secretary on a 
                supplemental application shall be in accordance with 
                subsection (d), and any order resulting from such 
                supplement shall be treated as an amendment to a 
                technology certification order.
            ``(2) Content of application.--
                    ``(A) In general.--A supplemental application for a 
                change to an in vitro clinical test under a technology 
                certification order shall--
                            ``(i) contain all necessary information to 
                        make a showing that any in vitro clinical test 
                        affected by such change that is within the 
                        scope of the technology certification order 
                        will meet the applicable standard; and
                            ``(ii) be limited to such information that 
                        is needed to support the change.
                    ``(B) Content.--Unless otherwise specified by the 
                Secretary, a supplemental application under this 
                subsection shall include--
                            ``(i) a description of the change, 
                        including a rationale for implementing such 
                        change;
                            ``(ii) a description of how the change was 
                        evaluated;
                            ``(iii) data from a representative in vitro 
                        clinical test or tests that supports a showing 
                        that, in using the modified procedure or 
                        procedures, all eligible in vitro clinical 
                        tests within the scope of the technology 
                        certification will meet the applicable 
                        standard;
                            ``(iv) as applicable, information to 
                        demonstrate that the modified procedure or 
                        procedures submitted under subsection (c)(2)(F) 
                        continue to conform to applicable requirements 
                        under section 587K; and
                            ``(v) any other information requested by 
                        the Secretary.
            ``(3) Changes in response to a public health risk.--
                    ``(A) In general.--If the holder of a technology 
                certification makes a change to an in vitro clinical 
                test or tests to address a potential risk to public 
                health by adding a new specification or test method, 
                such holder may immediately implement such change and 
                shall submit a notification for such change to the 
                Secretary within 30 days.
                    ``(B) Content.--Any notification to the Secretary 
                under this paragraph shall include--
                            ``(i) a summary of the relevant change;
                            ``(ii) the rationale for implementing such 
                        change;
                            ``(iii)(I) if such a change necessitates a 
                        change to the procedures reviewed as part of 
                        the granted technology certification order, the 
                        modified procedures; or
                            ``(II) if the procedures were not changed, 
                        an explanation as to why they were not changed; 
                        and
                            ``(iv) if such a change necessitates a 
                        change to the procedures reviewed as part of 
                        the granted technology certification order, 
                        data from a representative in vitro clinical 
                        test or tests that support a showing that, in 
                        using the modified procedures, all eligible in 
                        vitro clinical tests within the scope of the 
                        technology certification will meet the 
                        applicable standard.
    ``(f) Temporary Hold.--
            ``(1) In general.--Subject to the process specified in 
        paragraph (2), and based on one or more findings under 
        paragraph (4), the Secretary may issue a temporary hold 
        prohibiting any holder of a technology certification order 
        issued under this section from introducing into interstate 
        commerce an in vitro clinical test that was not previously the 
        subject of a listing under section 587J. The temporary hold 
        shall identify the grounds for the temporary hold under 
        paragraph (4) and the rationale for such finding.
            ``(2) Process for issuing a temporary hold.--If the 
        Secretary makes a finding that a temporary hold may be 
        warranted based on one or more grounds specified in paragraph 
        (4), the Secretary shall promptly notify the holder of the 
        technology certification order of such finding and provide 30 
        calendar days for the developer to come into compliance with or 
        otherwise resolve the finding.
            ``(3) Written requests.--Any written request to the 
        Secretary from the holder of a technology certification order 
        that a temporary hold under paragraph (1) be removed shall 
        receive a decision, in writing and specifying the reasons 
        therefore, within 90 days after receipt of such request. Any 
        such request shall include information to support the removal 
        of the temporary hold.
            ``(4) Grounds for temporary hold.--The Secretary may 
        initiate a temporary hold under this subsection upon a finding 
        that the holder of a technology certification order--
                    ``(A) is not in compliance with the conditions of 
                the technology certification order pursuant to 
                subsection (b)(1)(D);
                    ``(B) offers one or more in vitro clinical tests 
                with advertising or labeling that is false or 
                misleading;
                    ``(C) has reported a correction or removal of an in 
                vitro clinical test that is offered under a technology 
                certification order under this section and has failed 
                to demonstrate that the issue or issues causing the 
                correction or removal does not adversely impact the 
                ability of other in vitro clinical tests offered under 
                the same technology certification order to meet the 
                applicable standard; or
                    ``(D) has introduced into interstate commerce an in 
                vitro clinical test under a technology certification 
                order and such test is adulterated or misbranded, based 
                on a determination by the Secretary, and has failed to 
                demonstrate that the issue or issues causing the 
                adulteration or misbranding does not adversely impact 
                the ability of other in vitro clinical tests offered 
                under the same technology certification granted under 
                this section to meet the applicable standard.
    ``(g) Withdrawal.--The Secretary may, after due notice and 
opportunity for an informal hearing, issue an order withdrawing a 
technology certification order including all tests introduced into 
interstate commerce under the technology certification order if the 
Secretary finds that--
            ``(1) the application, supplement, or report under 
        subsection (h) contains false or misleading information or 
        fails to reveal a material fact;
            ``(2) such holder fails to correct false or misleading 
        labeling or advertising upon the request of the Secretary;
            ``(3) in connection with a technology certification, the 
        holder provides false or misleading information to the 
        Secretary; or
            ``(4) the holder of such technology certification order 
        fails to correct the grounds for a temporary hold within a 
        timeframe specified in the temporary hold order.
    ``(h) Reports to Congress.--
            ``(1) In general.--Not later than 1 year after the 
        effective date of the VALID Act of 2023, and annually 
        thereafter for the next 4 years, the Secretary shall submit to 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, and make publicly available, including through 
        posting on the website of the Food and Drug Administration, a 
        report containing the information described in paragraph (2).
            ``(2) Content.--
                    ``(A) In general.--Each report under paragraph (1) 
                shall address, at a minimum--
                            ``(i) the total number of applications for 
                        technology certifications filed, issued, 
                        withdrawn, and denied;
                            ``(ii) the total number of technology 
                        certification orders the Secretary put on 
                        temporary hold under subsection (h) and the 
                        number of technology certification orders 
                        withdrawn under subsection (i);
                            ``(iii) the types of technologies for which 
                        the Secretary issued technology certification 
                        orders;
                            ``(iv) the total number of holders of 
                        technology certification orders that are in 
                        effect; and
                            ``(v) the total number of in vitro clinical 
                        test categories that required premarket review 
                        under section 587B that were redesignated as 
                        eligible in vitro clinical tests under this 
                        section.
                    ``(B) Final report.--The fifth report submitted 
                under paragraph (1) shall include a summary of, and 
                responses to, comments raised in the docket.
                    ``(C) Performance reports.--The reports required 
                under this section may be issued with performance 
                reports as required under section 9 of the VALID Act of 
                2023.
    ``(i) Public Meeting and Input.--
            ``(1) Public docket.--Not later than 30 days after the date 
        of enactment of the VALID Act of 2023, the Secretary shall 
        establish a public docket to receive comments concerning 
        recommendations for implementation of this section, including 
        criteria and procedures for subsections (c) through (h). The 
        public docket shall remain open for at least 1 year after the 
        establishment of the public docket.
            ``(2) Public meeting.--Not later than 180 days after the 
        date of enactment of the VALID Act of 2023, the Secretary shall 
        convene a public meeting to which stakeholders from 
        organizations representing patients and consumers, academia, 
        and the in vitro clinical test industry are invited to discuss 
        the technology certification process including application 
        requirements, inspections, alignment with third-party 
        accreditors, and the definition of the term `technology' under 
        section 587.
    ``(j) Regulations.--The Secretary shall issue regulations regarding 
the technology certification process, including describing criteria or 
procedures relating to technology certification under this section, 
which shall be subject to public comment for a minimum of 60 days from 
issuance prior to finalizing such regulations after considering the 
comments received. The regulation shall include an outline of the 
application process, opportunities to meet with officials of the Food 
and Drug Administration, and plans to streamline inspections.
    ``(k) Notification.--
            ``(1) In general.--Notwithstanding subsection (a)(1), a 
        first-of-a-kind in vitro clinical test or a combination product 
        that meets the definition of a moderate-risk test under section 
        587 may be introduced into interstate commerce under a 
        technology certification order that has been issued by the 
        Secretary, subject to other applicable requirements if--
                    ``(A) the developer provides notification to the 
                Secretary 60 days prior to introducing such tests into 
                interstate commerce that includes information 
                demonstrating that the test is moderate-risk and within 
                the scope of the applicable technology certification 
                order; and
                    ``(B) the Secretary has not issued a notification 
                to the developer under paragraph (2) before such time 
                has elapsed.
            ``(2) Notification from secretary.--The Secretary shall 
        issue a notification to the developer that such test may not be 
        introduced into interstate commerce under such order if the 
        Secretary determines that--
                    ``(A) such test--
                            ``(i) does not meet the definition of a 
                        moderate-risk test under section 587;
                            ``(ii) is not eligible to be introduced 
                        into interstate commerce under any of 
                        subparagraphs (A) through (E) of subsection 
                        (a)(1); or
                            ``(iii) is not eligible to be introduced 
                        into interstate commerce under the referenced 
                        technology certification order issued by the 
                        Secretary because it is not within the scope of 
                        the technology certification order under 
                        subsection (b)(2); or
                    ``(B) based on the information included in the 
                notification submitted by the developer pursuant to 
                this subsection, there is insufficient information for 
                the Secretary to make the determinations described in 
                clauses (i), (ii), and (iii) of subparagraph (A).

``SEC. 587E. MITIGATING MEASURES.

    ``(a) Establishment of Mitigating Measures.--
            ``(1) Establishing, changing, or withdrawing.--
                    ``(A) Establishment.--The Secretary may establish 
                and require, on the basis of evidence, mitigating 
                measures for any in vitro clinical test or category of 
                in vitro clinical tests with the same indications for 
                use that is introduced or delivered for introduction 
                into interstate commerce after the Secretary 
                establishes any such mitigating measures.
                    ``(B) Methods of establishment.--The Secretary may 
                establish mitigating measures--
                            ``(i) under the process set forth in 
                        subparagraph (D);
                            ``(ii) as provided under section 587F; or
                            ``(iii) through a premarket approval or 
                        technology certification order, which may 
                        establish mitigating measures for an individual 
                        in vitro clinical test or a category of in 
                        vitro clinical tests.
                    ``(C) Methods of change or withdrawal.--The 
                Secretary may change or withdraw mitigating measures--
                            ``(i) under the process set forth in 
                        subparagraph (D); or
                            ``(ii) as provided under section 587F.
                    ``(D) Process for establishment, change, or 
                withdrawal.--Notwithstanding subchapter II of chapter 5 
                of title 5, United States Code, the Secretary may, upon 
                the initiative of the Secretary or upon petition of an 
                interested person, establish, change, or withdraw 
                mitigating measures for an in vitro clinical test or 
                category of in vitro clinical tests by--
                            ``(i) publishing a proposed order in the 
                        Federal Register;
                            ``(ii) providing an opportunity for public 
                        comment for a period of not less than 30 60 
                        calendar days; and
                            ``(iii) after consideration of any comments 
                        submitted, publishing a final order in the 
                        Federal Register that responds to the comments 
                        submitted, and which shall include a reasonable 
                        transition period.
                    ``(E) Effect of mitigating measures on 
                grandfathered tests.--A mitigating measure shall not be 
                required by the Secretary for an in vitro clinical test 
                subject to section 587G(a).
            ``(2) In vitro clinical tests previously cleared or exempt 
        as devices with special controls.--
                    ``(A) In general.--Any special controls applicable 
                to an in vitro clinical test previously cleared or 
                exempt under section 510(k), or classified under 
                section 513(f)(2) prior to date of enactment of the 
                VALID Act of 2023, including any such special controls 
                established during the period beginning on the date of 
                enactment of the VALID Act of 2023 and ending on the 
                effective date of such Act (as described in section 
                5(b) of such Act)--
                            ``(i) shall continue to apply to such in 
                        vitro clinical test after such effective date; 
                        and
                            ``(ii) are deemed to be mitigating measures 
                        as of the effective date specified in section 
                        5(a)(1)(A) of the VALID Act of 2023.
                    ``(B) Changes.--Notwithstanding subparagraph (A), 
                the Secretary may establish, change, or withdraw 
                mitigating measures for such tests or category of tests 
                using the procedures under paragraph (1).
    ``(b) Documentation.--
            ``(1) In vitro clinical tests subject to premarket 
        review.--The developer of an in vitro clinical test subject to 
        premarket review under section 587B and to which mitigating 
        measures apply shall maintain documentation in accordance with 
        the applicable quality requirements under section 587K and make 
        such documentation available to the Secretary upon request or 
        inspection.
            ``(2) Other tests.--The developer of an in vitro clinical 
        test that is offered under a technology certification order or 
        other exemption from premarket review under section 587B and to 
        which mitigating measures apply shall--
                    ``(A) maintain documentation in accordance with the 
                applicable quality requirements under section 587K 
                demonstrating that such mitigating measures continue to 
                be met following a test modification by the developer;
                    ``(B) make such documentation available to the 
                Secretary upon request or inspection; and
                    ``(C) include in the performance summary for such 
                test a brief description of how such mitigating 
                measures are met, if applicable.

``SEC. 587F. REGULATORY PATHWAY DESIGNATION.

    ``(a) Pathway Determinations.--
            ``(1) In general.--After considering available evidence 
        with respect to an in vitro clinical test or category of in 
        vitro clinical tests with the same intended use, including the 
        identification, establishment under paragraph (4), and 
        implementation of mitigating measures under section 587E, as 
        appropriate, the Secretary may, upon the initiative of the 
        Secretary or upon request of a developer, determine that--
                    ``(A) such in vitro clinical test is high-risk and 
                subject to premarket review under section 587B;
                    ``(B) such in vitro clinical tests, including a 
                first-of-a-kind test, is moderate-risk and subject to 
                abbreviated premarket review under section 587B(b) or 
                technology certification under section 587D(a)(1); or
                    ``(C) such in vitro clinical test, including a 
                first-of-a-kind test is low-risk or otherwise exempt 
                from premarket review under section 587B.
            ``(2) Requests.--
                    ``(A) Submissions by developers.--
                            ``(i) Abbreviated premarket review; 
                        technology certification.--A developer 
                        submitting a request that the Secretary make a 
                        determination as described in paragraph (1)(B) 
                        shall submit information to support that the in 
                        vitro clinical test is moderate-risk or propose 
                        mitigating measures, if applicable, that would 
                        support such a determination.
                            ``(ii) Low-risk; exempt from premarket 
                        review.--A developer submitting a request that 
                        the Secretary make a determination as described 
                        in paragraph (1)(C) shall submit information 
                        that the in vitro clinical test is low-risk, or 
                        otherwise appropriate for exemption from 
                        premarket review under section 587B and propose 
                        mitigating measures, if applicable, that would 
                        support such a determination.
                    ``(B) Response by the secretary.--Not later than 30 
                days after receiving a request under clause (i) or (ii) 
                of subparagraph (A), the Secretary shall provide a 
                timely response describing whether or not the Secretary 
                will initiate the process for making a determination 
                under paragraph (1)(B) or (1)(C) as described in 
                paragraph (4).
            ``(3) Sufficiency of mitigating measures.--When determining 
        whether mitigating measures for an in vitro clinical test, or 
        category of in vitro clinical tests, are sufficient to make 
        such test moderate-risk or low-risk, the Secretary shall take 
        into account the following:
                    ``(A) The degree to which the technology for the 
                intended use of the in vitro clinical test is well-
                characterized, taking into consideration factors that 
                include one or more of the following:
                            ``(i) Peer-reviewed literature.
                            ``(ii) Practice guidelines.
                            ``(iii) Consensus standards.
                            ``(iv) Recognized standards of care.
                            ``(v) Use of such technology, including 
                        historical use.
                            ``(vi) Multiple scientific publications by 
                        different authors.
                            ``(vii) Adoption by the scientific or 
                        clinical community.
                            ``(viii) Real world evidence.
                    ``(B) Whether the criteria for performance of the 
                test are well-established to be sufficient for the 
                intended use.
                    ``(C) The clinical circumstances under which the in 
                vitro clinical test is used, including whether the in 
                vitro clinical test is the sole determinate for the 
                diagnosis or treatment of the targeted disease, and the 
                availability of other tests (such as confirmatory or 
                adjunctive tests) or relevant material standards.
                    ``(D) Whether such mitigating measures sufficiently 
                mitigate the risk of harm such that the test or 
                category of tests is moderate-risk or low-risk.
            ``(4) Process.--
                    ``(A) In general.--For a test that is not first-of-
                a-kind, any action under paragraph (1) shall be made by 
                publication of a notice of such proposed action on the 
                website of the Food and Drug Administration, the 
                consideration of comments to a public docket on such 
                proposal, and publication of a final action on such 
                website within 60 calendar days of the close of the 
                comment period posted to such public docket, 
                notwithstanding subchapter II of chapter 5 of title 5, 
                United States Code.
                    ``(B) Process for first-of-a-kind test.--In the 
                case of an in vitro clinical test that is first-of-a-
                kind, the process is as follows:
                            ``(i) Any determination that the test is 
                        subject to premarket approval or abbreviated 
                        premarket review under subparagraph (A) or (B) 
                        of paragraph (1) shall be published on the 
                        website of the Food and Drug Administration, 
                        notwithstanding subclause II of chapter 5 of 
                        title 5, United States Code, only after the in 
                        vitro clinical test is approved under section 
                        587B. Until that time, the determination shall 
                        not be binding on other in vitro clinical 
                        tests.
                            ``(ii) Any determination other than those 
                        made under clause (i) shall be made by 
                        publication of a notice of final action on the 
                        website of the Food and Drug Administration, 
                        notwithstanding subchapter II of chapter 5 of 
                        title 5, United States Code.
            ``(5) No effect on grandfathering determinations.--A 
        determination under paragraph (1) shall have no effect on the 
        applicability of section 587G to an in vitro clinical tests.
    ``(b) Transition Period.--Upon a decision by the Secretary to 
change a regulatory pathway designation, or reclassifies an in vitro 
clinical test, or category of in vitro clinical tests, the Secretary 
shall provide an appropriate transition period with respect to any new 
requirements.
    ``(c) Appeals.--A decision by the Secretary under this section 
shall be deemed a significant decision subject to appeal under section 
587P.
    ``(d) Advisory Committee.--The Secretary may request 
recommendations from an advisory committee under section 587H pursuant 
to carrying out this section.
    ``(e) Request for Informal Feedback.--Before submitting a premarket 
application or technology certification application for an in vitro 
clinical test--
            ``(1) the developer of the test may submit to the Secretary 
        a written request for a meeting, conference, or written 
        feedback to discuss and provide information relating to the 
        regulation of such in vitro clinical test which may include--
                    ``(A) the submission process and the type and 
                amount of evidence expected to demonstrate the 
                applicable standard;
                    ``(B) which regulatory pathway is appropriate for 
                an in vitro clinical test; and
                    ``(C) an investigation plan for an in vitro 
                clinical test, including a clinical protocol; and
            ``(2) upon receipt of such a request, the Secretary shall--
                    ``(A) if a meeting is requested--
                            ``(i) within 60 calendar days after such 
                        receipt, or within such time period as may be 
                        agreed to by the developer, meet or confer with 
                        the developer submitting the request; and
                            ``(ii) within 15 calendar days after such 
                        meeting or conference, provide to the developer 
                        a written record or response describing the 
                        issues discussed and conclusions reached in the 
                        meeting or conference; and
                    ``(B) if written feedback is requested, provide 
                feedback to the requestor within 75 days after such 
                receipt.

``SEC. 587G. GRANDFATHERED IN VITRO CLINICAL TESTS.

    ``(a) In General.--Subject to subsection (d), an in vitro clinical 
test is exempt from the requirements of this subchapter specified in 
subsection (b) if--
            ``(1) the test was first offered for clinical use, and was 
        not intended solely for investigational use, not later than 45 
        days after the date of enactment of the VALID Act of 2023;
            ``(2) the test was developed by a clinical laboratory for 
        which a certificate was in effect under section 353 of the 
        Public Health Service Act that meets the requirements for 
        performing tests of high complexity;
            ``(3) the test is performed--
                    ``(A) in the same clinical laboratory in which the 
                test was developed for which a certification is still 
                in effect under section 353 of the Public Health 
                Service Act that meets the requirements to perform 
                tests of high complexity;
                    ``(B) by another clinical laboratory for which a 
                certificate is in effect under section 353 of such Act 
                that meets the requirements to perform tests of high 
                complexity, and that is within the same corporate 
                organization and having common ownership by the same 
                parent corporation as the laboratory in which the test 
                was developed; or
                    ``(C) in the case of a test that was developed by 
                the Centers for Disease Control and Prevention or 
                another laboratory in a public health laboratory 
                network coordinated or managed by the Centers for 
                Disease Control and Prevention, by a clinical 
                laboratory for which a certificate is in effect under 
                section 353 of such Act that meets the requirements to 
                perform tests of high complexity, and that is within a 
                public health laboratory network coordinated or managed 
                by the Centers for Disease Control and Prevention;
            ``(4) the test does not have in effect an approval under 
        section 515, a clearance under section 510(k), an authorization 
        under section 513(f)(2), or an exemption under section 520(m), 
        or licensure under section 351 of the Public Health Service 
        Act;
            ``(5) any modification to the test on or after the date 
        that is 45 days after the date of enactment of the VALID Act of 
        2023 is made by the initial developer, conforms with section 
        587C(a)(6)(A)(ii), and does not meet the criteria in subsection 
        (d)(1);
            ``(6) when used as an investigational in vitro clinical 
        test, such test complies with section 587S, as applicable;
            ``(7) the test is offered with an order from an authorized 
        person as required under section 353 of the Public Health 
        Service Act, and was offered with a prescription required under 
        section 809.30(f) of title 21, Code of Federal Regulations 
        prior to the effective date of this subchapter;
            ``(8) the test is not for use with home specimen 
        collection, unless the specimen is collected with a collection 
        container, receptacle, or kit that--
                    ``(A) has been approved, cleared, or authorized by 
                the Secretary for home specimen collection and the 
                collection is performed pursuant to the approved, 
                cleared, or authorized labeling, including any 
                indication for use as prescription use or over-the-
                counter use, or
                    ``(B) is exempt from premarket review and its use 
                is consistent with applicable limitations on the 
                exemption;
            ``(9) the test is not a specimen receptacle or instrument;
            ``(10) each test report for the test bears a statement that 
        reads as follows: `This in vitro clinical test was introduced 
        into commerce prior to the application of the VALID Act and is 
        exempt from FDA premarket review.'; and
            ``(11) the developer of the test--
                    ``(A) maintains documentation demonstrating that 
                the test meets and continues to meet the criteria set 
                forth in this subsection; and
                    ``(B) makes such documentation available to the 
                Secretary upon request.
    ``(b) Exemptions Applicable to Grandfathered Tests.--An in vitro 
clinical test that meets the criteria specified in subsection (a) is 
exempt from premarket review under 587B, labeling requirements under 
587L, and test design requirements and quality requirements under 587K, 
and may be lawfully offered subject to the other applicable 
requirements of this Act.
    ``(c) Modifications.--In the case of an in vitro clinical test that 
meets the criteria specified in subsection (a), such test continues to 
qualify for the exemptions described in subsection (b) if the test is 
modified and the modification is of a type described in subsection 
(a)(5), and the person modifying such in vitro clinical test--
            ``(1) documents each such modification and maintains 
        documentation of the basis for such determination;
            ``(2) provides such documentation relating to the change to 
        the Secretary upon request or inspection; and
            ``(3) does not modify the in vitro clinical test such that 
        it no longer meets the criteria under subsection (a).
    ``(d) Request for Information.--
            ``(1) Criteria.--The criteria described in this paragraph 
        are any of the following:
                    ``(A) There is a lack of valid scientific evidence 
                to support that the in vitro clinical test is 
                analytically valid or clinically valid.
                    ``(B) Such in vitro clinical test is being offered 
                by its developer with any false or misleading 
                analytical or clinical claims.
                    ``(C) It is probable that such in vitro clinical 
                test will cause serious adverse health consequences.
            ``(2) Process.--
                    ``(A) Written request for information.--The 
                Secretary may issue a written request to a developer 
                identifying specific scientific concerns, based on 
                credible information, with an in vitro clinical test, 
                which indicate that one or more of the criteria 
                described in paragraph (1) apply to such in vitro 
                clinical test. Such written request shall include 
                specific information requests pertaining to such 
                criteria.
                    ``(B) Deadline for submitting information.--Not 
                later than 45 days after receiving a request for 
                information under subparagraph (A)--
                            ``(i) the developer of an in vitro clinical 
                        test--
                                    ``(I) may seek a teleconference 
                                prior to the submission of information 
                                under subclause (II) to discuss the 
                                Secretary's request; and
                                    ``(II) shall submit the information 
                                requested pursuant to subparagraph (A), 
                                and may include in such submission a 
                                request for a teleconference; and
                            ``(ii) the Secretary shall--
                                    ``(I) schedule a teleconference 
                                requested under clause (i)(I); and
                                    ``(II) hold a teleconference if 
                                requested within 10 days of the 
                                Secretary's receipt of the information 
                                submitted under clause (i)(II).
                    ``(C) Review deadline.--Upon receiving a submission 
                under subparagraph (B), the Secretary shall--
                            ``(i) review the submitted information 
                        within 45 calendar days of such receipt, which 
                        may include communication with the developer; 
                        and
                            ``(ii) determine whether the criteria 
                        listed in paragraph (1) apply to the in vitro 
                        clinical test and communicate such 
                        determination to the developer as described in 
                        subparagraph (D).
                    ``(D) Communication and results of determination.--
                The Secretary shall notify the developer, in writing, 
                of the Secretary's determination under subparagraph 
                (C), as follows:
                            ``(i) If the Secretary determines that none 
                        of the criteria listed in paragraph (1) apply 
                        to the in vitro clinical test, such test shall 
                        be exempt from relevant requirements of this 
                        subchapter, as set forth in subsection (b), 
                        subject to the criteria under subsection (a).
                            ``(ii) If the Secretary determines that one 
                        or more of the criteria listed in paragraph (1) 
                        apply to the test but such a determination may 
                        be resolved within a reasonable time, and the 
                        test has not been previously subject to this 
                        subsection on the basis of the same or 
                        substantially similar scientific concerns 
                        identified in the written request issued under 
                        paragraph (d)(2)(A)--
                                    ``(I) the Secretary shall notify 
                                the developer of such a determination 
                                and allow the developer to seek a 
                                teleconference to discuss the finding;
                                    ``(II) the developer shall submit 
                                information demonstrating resolution of 
                                the determination within 15 days of 
                                receiving such notification; and
                                    ``(III) the Secretary shall make a 
                                determination within 30 days of the 
                                receipt of such submission of 
                                information as to whether the criteria 
                                under paragraph (1) continue to apply 
                                to the test and, if through such 
                                determination the Secretary determines 
                                that--
                                            ``(aa) none of the criteria 
                                        listed in paragraph (1) apply 
                                        to the test, such test shall be 
                                        exempt from relevant 
                                        requirements of the subchapter 
                                        as set forth in subsection (b), 
                                        subject to applicable 
                                        limitations; or
                                            ``(bb) one or more of the 
                                        criteria listed in paragraph 
                                        (1) apply to the in vitro 
                                        clinical test, such test is not 
                                        exempt as set forth in this 
                                        section and shall not be 
                                        offered unless approved under 
                                        section 587B, or, upon a 
                                        determination by the Secretary 
                                        pursuant to section 587F, 
                                        offered under a technology 
                                        certification order under 
                                        section 587D or offered as a 
                                        low-risk test.
                            ``(iii) If the Secretary determines that 
                        one or more of the criteria listed in paragraph 
                        (1) apply to the in vitro clinical test and 
                        clause (ii) does not apply, the in vitro 
                        clinical test is not exempt as set forth in 
                        this section and shall not be offered unless 
                        approved under section 587B, or upon a 
                        determination by the Secretary pursuant to 
                        section 587F, offered under a technology 
                        certification order under section 587D or 
                        offered as a low-risk test.

``SEC. 587H. ADVISORY COMMITTEES.

    ``(a) In General.--The Secretary may establish advisory committees 
or use advisory committee panels of experts established before the date 
of enactment of the VALID Act of 2023 (including a device 
classification panel under section 513) for the purposes of providing 
expert scientific advice and making recommendations related to--
            ``(1) the approval of an application for an in vitro 
        clinical test submitted under this subchapter, including for 
        evaluating, as applicable, the analytical validity, clinical 
        validity, and safety of in vitro clinical tests;
            ``(2) the potential effectiveness of mitigating measures 
        for a determination of the applicable regulatory pathway under 
        section 587F(b) or risk evaluation for an in vitro clinical 
        test or tests;
            ``(3) quality requirements under section 587K or applying 
        such requirements to in vitro clinical tests developed or 
        imported by developers;
            ``(4) appeals under section 587P; or
            ``(5) such other purposes as the Secretary determines 
        appropriate.
    ``(b) Appointments.--
            ``(1) Voting members.--The Secretary shall appoint to each 
        committee established under subsection (a), as voting members, 
        individuals who are qualified by training and experience to 
        evaluate in vitro clinical tests referred to the committee for 
        the purposes specified in subsection (a), including individuals 
        with, to the extent feasible, scientific expertise in the 
        development of such in vitro clinical tests, laboratory 
        operations, and the use of in vitro clinical tests. The 
        Secretary shall designate one member of each committee to serve 
        as chair.
            ``(2) Nonvoting members.--In addition to the individuals 
        appointed pursuant to paragraph (1), the Secretary shall 
        appoint to each committee established under subsection (a), as 
        nonvoting members--
                    ``(A) a representative of consumer interests; and
                    ``(B) a representative of interests of in vitro 
                clinical test developers not directly affected by the 
                matter to be brought before the committee.
            ``(3) Limitation.--No individual who is a regular full-time 
        employee of the United States and engaged in the administration 
        of this Act may be a member of any advisory committee 
        established under subsection (a).
            ``(4) Education and training.--The Secretary shall, as 
        appropriate, provide education and training to each new 
        committee member before such member participates in a 
        committee's activities, including education regarding 
        requirements under this Act and related regulations of the 
        Secretary, and the administrative processes and procedures 
        related to committee meetings.
            ``(5) Meetings.--The Secretary shall ensure that scientific 
        advisory committees meet regularly and at appropriate intervals 
        so that any matter to be reviewed by such a committee can be 
        presented to the committee not more than 60 calendar days after 
        the matter is ready for such review. Meetings of the committee 
        may be held using electronic or telephonic communication to 
        convene the meetings.
            ``(6) Compensation.--Members of an advisory committee 
        established under subsection (a), while attending meetings or 
        conferences or otherwise engaged in the business of the 
        advisory committee--
                    ``(A) shall be entitled to receive compensation at 
                rates to be fixed by the Secretary, but not to exceed 
                the daily equivalent of the rate in effect for 
                positions classified above level GS-15 of the General 
                Schedule; and
                    ``(B) may be allowed travel expenses as authorized 
                by section 5703 of title 5, United States Code, for 
                employees serving intermittently in the Government 
                service.
    ``(c) Guidance.--The Secretary may issue guidance on the policies 
and procedures governing advisory committees established under 
subsection (a).

``SEC. 587I. BREAKTHROUGH IN VITRO CLINICAL TESTS.

    ``(a) In General.--The purpose of this section is to encourage the 
Secretary, and provide the Secretary with sufficient authority, to 
apply efficient and flexible approaches to expedite the development of, 
and prioritize the review of, in vitro clinical tests that represent 
breakthrough technologies.
    ``(b) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide for the priority 
review of, in vitro clinical tests.
    ``(c) Eligibility.--The program developed under subsection (b) 
shall be available for any in vitro clinical test that--
            ``(1) provides or enables more effective treatment or 
        diagnosis of life-threatening or irreversibly debilitating 
        human disease or conditions; and
            ``(2) is a test--
                    ``(A) that represents a breakthrough technology;
                    ``(B) for which no approved alternative in vitro 
                clinical test exists, including no in vitro clinical 
                test offered under a technology certification order;
                    ``(C) that offers a clinically meaningful advantage 
                over existing alternative in vitro clinical tests that 
                are approved (including in vitro clinical tests offered 
                under a technology certification order), including the 
                potential to reduce or eliminate the need for 
                hospitalization, improve patient quality of life, 
                facilitate patients' ability to manage their own care 
                (such as through self-directed personal assistance), or 
                establish long-term clinical efficiencies; or
                    ``(D) the availability of which is in the best 
                interest of patients or public health.
    ``(d) Designation.--
            ``(1) Request.--To receive breakthrough designation under 
        this section, an applicant may request that the Secretary 
        designate the in vitro clinical test for expedited development 
        and priority review. Any such request for designation may be 
        made at any time prior to, or at the time of, the submission of 
        an application under section 587B or 587D, and shall include 
        information demonstrating that the test meets the criteria 
        described in subsection (c).
            ``(2) Determination.--Not later than 60 calendar days after 
        the receipt of a request under paragraph (1), the Secretary 
        shall determine whether the in vitro clinical test that is the 
        subject of the request meets the criteria described in 
        subsection (c). If the Secretary determines that the test meets 
        the criteria, the Secretary shall designate the test for 
        expedited development and priority review.
            ``(3) Review.--Review of a request under paragraph (1) 
        shall be undertaken by a team that is composed of experienced 
        staff and senior managers of the Food and Drug Administration.
            ``(4) Withdrawal.--
                    ``(A) In general.--The designation of an in vitro 
                clinical test under this subsection is deemed to be 
                withdrawn, and such in vitro clinical test shall no 
                longer be eligible for designation under this section, 
                if an application for approval for such test under 
                section 587B or 587D is denied. Such test shall be 
                eligible for breakthrough designation upon a new 
                request for such designation.
                    ``(B) Exception.--The Secretary may not withdraw a 
                designation granted under this subsection based on the 
                subsequent approval or technology certification of 
                another in vitro clinical test that--
                            ``(i) is designated under this section; or
                            ``(ii) was given priority review under 
                        section 515B.
    ``(e) Actions.--For purposes of expediting the development and 
review of in vitro clinical tests under this section, the Secretary may 
take the actions and additional actions set forth in paragraphs (1) and 
(2), respectively, of section 515B(e) when reviewing such tests. Any 
reference or authorization in section 515B(e) with respect to a device 
shall be deemed a reference or authorization with respect to an in 
vitro clinical test for purposes of this section.
    ``(f) Guidance.--Not later than 30 months after the date of 
enactment of the VALID Act of 2023, the Secretary shall issue final 
guidance on the implementation of this section. Such guidance shall--
            ``(1) set forth the process by which a person may seek a 
        designation under subsection (d);
            ``(2) provide a template for request under subsection (d);
            ``(3) identify the criteria the Secretary will use in 
        evaluating a request for designation; and
            ``(4) identify the criteria and processes the Secretary 
        will use to assign a team of staff, including team leaders, to 
        review in vitro clinical tests designated for expedited 
        development and priority review, including any training 
        required for such personnel to ensure effective and efficient 
        review.
    ``(g) Rules of Construction.--Nothing in this section shall be 
construed to affect--
            ``(1) the criteria and standards for evaluating an 
        application pursuant to section 587B or 587D, including the 
        recognition of valid scientific evidence as described in 
        section 587(20) and consideration and application of the least 
        burdensome means described under section 587AA(c);
            ``(2) the authority of the Secretary with respect to 
        clinical holds under section 587S;
            ``(3) the authority of the Secretary to act on an 
        application pursuant to section 587B before completion of an 
        establishment inspection, as the Secretary determines 
        appropriate; or
            ``(4) the authority of the Secretary with respect to 
        postmarket surveillance under section 587X.

``SEC. 587J. REGISTRATION AND LISTING.

    ``(a) Registration Requirement.--
            ``(1) In general.--Each person described in subsection 
        (b)(1) shall--
                    ``(A) during the period beginning on October 1 and 
                ending on December 31 of each year, register with the 
                Secretary the name of such person, places of business 
                of such person, all establishments engaged in the 
                activities specified under this paragraph, the 
                establishment registration number of each such 
                establishment, and a point of contact for each such 
                establishment, including an electronic point of 
                contact; and
                    ``(B) submit an initial registration containing the 
                information required under subparagraph (A)--
                            ``(i) in accordance with the timelines for 
                        submission under subsection (c), if the 
                        establishment is engaged in any activity 
                        described in subsection (b)(1) on the effective 
                        date of this section, unless the Secretary 
                        establishes by guidance a date later than such 
                        date for all or a category of such 
                        establishments; or
                            ``(ii) not later than 30 days prior to 
                        engaging in any activity described in 
                        subsection (b)(1), if the establishment is not 
                        engaged in any activity described in this 
                        paragraph on the effective date of this 
                        section.
            ``(2) Registration numbers.--The Secretary may assign a 
        registration number to any person or an establishment 
        registration number to any establishment registered in 
        accordance with this section. Registration information shall be 
        made publicly available by publication on the website 
        maintained by the Food and Drug Administration, in accordance 
        with subsection (d).
            ``(3) Inspection.--Each person or establishment that is 
        required to be registered with the Secretary under this section 
        shall be subject to inspection pursuant to section 704.
    ``(b) Listing Information for In Vitro Clinical Tests.--
            ``(1) In general.--Each person who--
                    ``(A) is a developer; and
                    ``(B) introduces or proposes to begin the 
                introduction or delivery for introduction into 
                interstate commerce through an exemption under 
                subsection (a)(1), (a)(2), (a)(3), or (g) of section 
                587C or section 587G or through the filing of an 
                application under section 587B or section 587D,
        shall submit a listing to the Secretary containing the 
        information described in paragraph (2), or (4), as applicable, 
        in accordance with the applicable schedule described under 
        subsection (c). Such listing shall be prepared in such form and 
        manner as the Secretary may specify in guidance. Listing 
        information shall be submitted through the comprehensive test 
        information system in accordance with section 587T, as 
        appropriate.
            ``(2) Submissions.--Each developer submitting a listing 
        under paragraph (1) shall electronically submit to the 
        comprehensive test information system described in section 587T 
        the following information, as applicable, for each in vitro 
        clinical test for which such person is a developer in the form 
        and manner prescribed by the Secretary, taking into account the 
        least burdensome requirements under section 587AA(c):
                    ``(A) Name of the establishment and its 
                establishment registration number.
                    ``(B) Contact information for the official 
                correspondent for the listing.
                    ``(C) Name (common name and trade name, if 
                applicable) of the in vitro clinical test and its test 
                listing number (when available).
                    ``(D) The certificate number for any laboratory 
                certified by the Secretary under section 353 of the 
                Public Health Service Act that meets the requirements 
                to perform high-complexity testing and that is the 
                developer of the in vitro clinical test, and the 
                certificate number under such section for any 
                laboratory that is performing the test, is within the 
                same corporate organization, and has common ownership 
                by the same parent corporation.
                    ``(E) Whether the in vitro clinical test is, as 
                applicable, offered as a test approved under section 
                587B, offered under a granted technology certification 
                order, or offered as an exempt in vitro clinical test 
                under section 587C or 587G.
                    ``(F) Indications for use information under section 
                587(10).
                    ``(G) A brief summary of the analytical and 
                clinical performance of the in vitro clinical test, and 
                as applicable, the lot release criteria.
                    ``(H) A brief description of conformance with any 
                applicable mitigating measures, restrictions, and 
                standards.
                    ``(I) Representative labeling for the in vitro 
                clinical test, as appropriate.
            ``(3) Test listing number.--The Secretary may assign a test 
        listing number to each in vitro clinical test that is the 
        subject of a listing under this section. The process for 
        assigning test listing numbers may be established through 
        guidance, and may include the recognition of standards, 
        formats, or conventions developed by a third-party 
        organization.
            ``(4) Grandfathered tests.--A developer offering a test 
        that is a grandfathered in vitro clinical test under section 
        587G(a) shall submit listing information required under 
        subparagraphs (A) through (F) of paragraph (2), and may submit 
        a statement of the performance specifications for such in vitro 
        clinical tests.
            ``(5) Exempt tests.--A developer of an in vitro clinical 
        test who introduces or proposes to begin the introduction or 
        delivery for introduction into interstate commerce that is 
        otherwise exempt from the requirement to submit listing 
        information pursuant to an exemption under section 587C may 
        submit listing information under this subsection.
    ``(c) Timelines for Submission of Listing Information.--
            ``(1) In general.--The timelines for submission of 
        registration and listing under subsections (a) and (b) are as 
        follows:
                    ``(A) For an in vitro clinical test that was listed 
                as a device under section 510(j) prior to the effective 
                date of this section, a person shall maintain a device 
                listing under section 510 until such time as the system 
                for submitting the listing information required under 
                subsection (b) becomes available and thereafter shall 
                submit the listing information not later than the later 
                of 1 year after the system for submitting the listing 
                under this section becomes available or the effective 
                date of this section.
                    ``(B) For an in vitro clinical test that is subject 
                to grandfathering under section 587G(a) a person shall 
                submit the listing information required under 
                subsection (b)(4) within 10 calendar days of offering 
                the test after the effective date of this section.
                    ``(C) For an in vitro clinical test that is not 
                described in subparagraph (A) or (B), a person shall 
                submit the required listing information as follows:
                            ``(i) For an in vitro clinical test that is 
                        not exempt from premarket approval under 
                        section 587B, a person shall submit the 
                        required listing information, prior to offering 
                        the in vitro clinical test and not later than 
                        30 business days after the date of approval of 
                        the premarket approval application.
                            ``(ii) For an in vitro clinical test that 
                        is exempt from premarket review under section 
                        587C, the required listing information shall be 
                        submitted prior to offering the in vitro 
                        clinical test.
            ``(2) Updates.--
                    ``(A) Updates after changes.--Each developer 
                required to submit listing information under this 
                section shall update such information within 10 
                business days of any change that causes any previously 
                listed information to be inaccurate or incomplete.
                    ``(B) Annual updates.--Each developer required to 
                submit listing information under this section shall 
                update its information annually during the period 
                beginning on October 1 and ending on December 31 of 
                each year.
    ``(d) Public Availability of Listing Information.--
            ``(1) In general.--Listing information submitted pursuant 
        to this section shall be made publicly available on the website 
        of the Food and Drug Administration in accordance with 
        paragraph (3).
            ``(2) Confidentiality.--Listing information for an in vitro 
        clinical test that is subject to premarket approval or 
        technology certification shall remain confidential until such 
        date as the in vitro clinical test receives the applicable 
        premarket approval or the developer receives a technology 
        certification order and for subsequent tests introduced under a 
        technology certification order until their introduction.
            ``(3) Exceptions from public availability requirements.--
        The public listing requirements of this subsection shall not 
        apply to any registration and listing information submitted 
        under subsection (a) or (b), if the Secretary determines that 
        such information--
                    ``(A) is a trade secret or confidential commercial 
                or financial information; or
                    ``(B) if posted, could compromise national 
                security.
    ``(e) Submission of Information by Accredited Persons.--If agreed 
upon by the developer, the information required under this section may 
be submitted by a person accredited under section 587Q.

``SEC. 587K. TEST DESIGN AND QUALITY REQUIREMENTS.

    ``(a) Applicability.--
            ``(1) In general.--Each developer shall establish and 
        maintain quality requirements in accordance with the applicable 
        requirements set forth in subsection (b).
            ``(2) Certified laboratory requirements.--A developer shall 
        establish and maintain quality requirement under subsection 
        (b)(2) or (b)(3), as applicable, if such developer is a 
        clinical laboratory certified by the Secretary under section 
        353 of the Public Health Service Act that--
                    ``(A) is certified to perform high-complexity 
                testing;
                    ``(B) develops an in vitro clinical test that is 
                for use only--
                            ``(i) within the laboratory certified by 
                        the Secretary under such section 353 in which 
                        such test was developed; or
                            ``(ii) within another laboratory certified 
                        by the Secretary under such section 353 if such 
                        laboratory is--
                                    ``(I) within the same corporate 
                                organization and has common ownership 
                                by the same parent corporation as the 
                                laboratory in which the test was 
                                developed; or
                                    ``(II) within a public health 
                                laboratory network coordinated or 
                                managed by the Centers for Disease 
                                Control and Prevention, if the test is 
                                developed by a public health laboratory 
                                or the Centers for Disease Control and 
                                Prevention; and
                    ``(C) does not manufacture, produce, or distribute 
                in vitro clinical tests other than laboratory test 
                protocols.
            ``(3) Regulations.--The Secretary shall promulgate quality 
        system regulations implementing this section. In promulgating 
        such regulations under this section, the Secretary shall 
        consider whether, and to what extent, international 
        harmonization is appropriate.
            ``(4) Quality systems for hybrid developers of both 
        laboratory test protocols and other in vitro clinical tests.--
        An entity that develops both laboratory test protocols and 
        other in vitro clinical tests shall comply with subsection 
        (b)(1) for activities related to the development of any in 
        vitro clinical test that is not a laboratory test protocol and 
        with subsection (b)(2) or (b)(3), as applicable, for activities 
        related to the development of any laboratory test protocol.
    ``(b) Quality Requirements.--
            ``(1) In general.--The quality requirements applicable 
        under this section shall--
                    ``(A) avoid duplication of regulations and guidance 
                under section 353 of the Public Health Service Act, 
                such that laboratories would not be subject to 
                conflicting regulatory obligations with respect to the 
                same activity;
                    ``(B) not apply to laboratory operations; and
                    ``(C) include, as applicable, subject to 
                subparagraphs (A) and (B) and paragraphs (2) and (3)--
                            ``(i) management responsibilities;
                            ``(ii) quality audits;
                            ``(iii) personnel;
                            ``(iv) design controls;
                            ``(v) document controls;
                            ``(vi) purchasing controls;
                            ``(vii) identification and traceability;
                            ``(viii) production and process controls;
                            ``(ix) acceptance activities;
                            ``(x) nonconforming in vitro clinical 
                        tests;
                            ``(xi) corrective and preventive action;
                            ``(xii) labeling and packaging controls;
                            ``(xiii) handling, storage, distribution, 
                        and installation;
                            ``(xiv) complaints and records;
                            ``(xv) servicing; and
                            ``(xvi) statistical techniques.
            ``(2) Exception for laboratory test protocols.--Developers 
        that are developing test protocols for use as described in 
        subsection (a)(2)(B)(i) are exempt from the requirements under 
        paragraph (1)(C) except for the requirements described in 
        clauses (iv), (ix), (xi), and (xiv) of such paragraph.
            ``(3) Quality requirements for certain laboratories 
        distributing laboratory test protocols within organizations or 
        public health networks.--Quality requirements applicable to the 
        developer who is distributing a laboratory test protocol as 
        described in subsection (a)(2)(B)(ii) shall consist of the 
        following:
                    ``(A) Clauses (iv), (ix), (xi), (xiv), (xii) of 
                paragraph (1)(B).
                    ``(B) The requirement to maintain records of the 
                laboratories to which the laboratory test protocol is 
                distributed.
    ``(c) Regulations.--In implementing quality requirements for test 
developers that participate in international audit programs under this 
section, the Secretary shall--
            ``(1) for purposes of facilitating international 
        harmonization, consider whether the developer participates in 
        an international audit program in which the United States 
        participates and recognizes compliance with, or conformance to, 
        such standards recognized by the Secretary; and
            ``(2) ensure a least burdensome approach described in 
        section 587AA(c) by leveraging, to the extent applicable, the 
        quality assurance requirements applicable to developers 
        certified by the Secretary under section 353 of the Public 
        Health Service Act.

``SEC. 587L. LABELING REQUIREMENTS.

    ``(a) In General.--An in vitro clinical test shall bear or be 
accompanied by labeling, as applicable, that meets the requirements set 
forth in subsections (b) and (c), unless such test is exempt under 
subsection (d) or (e).
    ``(b) Labels.--
            ``(1) In general.--The label of an in vitro clinical test, 
        shall meet the requirements set forth in paragraph (2) if there 
        is an immediate container to which the label is applied.
            ``(2) Regulations.--The label of an in vitro clinical test 
        shall state the name and place of business of its developer and 
        meet the requirements set forth in regulations promulgated in 
        accordance with this section.
    ``(c) Labeling.--
            ``(1) In general.--Labeling of an in vitro clinical test, 
        including labeling in the form of a package insert, website, 
        standalone laboratory reference document, or other similar 
        document shall include--
                    ``(A) adequate directions for use and shall meet 
                the requirements set forth in regulations promulgated 
                under this section, except as provided in subsection 
                (d) or (e); and
                    ``(B) the information described in paragraph (2), 
                as applicable.
            ``(2) Content.--Labeling of an in vitro clinical test shall 
        include--
                    ``(A) the test listing number that was provided to 
                the developer at the time of listing;
                    ``(B) information to facilitate reporting an 
                adverse event;
                    ``(C) information regarding accessing the 
                performance summary data displayed in the listing 
                database for the test;
                    ``(D) the indications for use of the in vitro 
                clinical test; and
                    ``(E) any warnings, contraindications, or 
                limitations.
            ``(3) Public availability of information.--The Secretary 
        shall make all of the information described in paragraph (2) 
        with respect to each in vitro clinical test available to the 
        public, as applicable, in accordance with section 587T, except 
        to the extent that the Secretary determines that such 
        information--
                    ``(A) is trade secret or confidential commercial or 
                financial information; or
                    ``(B) if posted, could compromise national 
                security.
            ``(4) Additional requirements.--Labeling for an in vitro 
        clinical test used for immunohematology testing shall meet the 
        applicable requirements set forth in part 660 of title 21, Code 
        of Federal Regulations (or any successor regulations), related 
        to the labeling of blood grouping reagents, reagent red blood 
        cells, and anti-human globulin.
    ``(d) Exemptions and Alternative Requirements.--
            ``(1) In general.--
                    ``(A) In general.--With respect to an in vitro 
                clinical test that meets the criteria of subparagraph 
                (B), the `state in one place' regulations under section 
                809.10(b) of title 21, Code of Federal Regulations (or 
                any successor regulations) may be satisfied by the 
                laboratory posting such information on its website or 
                in multiple documents, if such documents are maintained 
                and accessible in one place.
                    ``(B) Applicable tests.--An in vitro clinical test 
                meets the criteria of this subparagraph if such test 
                is--
                            ``(i) developed by a laboratory certified 
                        by the Secretary under section 353 of the 
                        Public Health Service Act that meets the 
                        requirements to perform tests of high-
                        complexity; and
                            ``(ii) performed in--
                                    ``(I) the same laboratory in which 
                                such test was developed; or
                                    ``(II) by another laboratory 
                                certified by the Secretary under 
                                section 353 of the Public Health 
                                Service Act that--
                                            ``(aa) meets the 
                                        requirements to perform tests 
                                        of high complexity; and
                                            ``(bb) is under common 
                                        ownership and control as the 
                                        laboratory that developed the 
                                        test.
            ``(2) Test instrument labeling.--Unless the instrument is 
        the entire test system, the labeling for an instrument is not 
        required to bear the information indicated in paragraphs (3), 
        (4), (5), (7), (8), (9), (10), (11), (12), and (13) of section 
        809.10(b) of title 21, Code of Federal Regulations (or any 
        successor regulations).
            ``(3) Reagent labeling.--For purposes of compliance with 
        subsection (c)(1), the labeling for a reagent intended for use 
        as a replacement in an in vitro clinical test may be limited to 
        that information necessary to identify the reagent adequately 
        and to describe its proper use in the test.
            ``(4) Investigational use.--A shipment or other delivery of 
        an in vitro clinical test for investigational use pursuant to 
        section 587S shall be exempt from the labeling requirements of 
        subsections (b) and (c)(1) and from any standard promulgated 
        through regulations, except as required under section 353 of 
        the Public Health Service Act or section 587R of this Act.
            ``(5) General purpose laboratory reagents.--The labeling of 
        general purpose laboratory reagents (such as hydrochloric acid) 
        whose uses are generally known by persons trained in their use 
        need not bear the directions for use required by subsection 
        (c)(1)(A).
            ``(6) Over-the-counter test specimen receptacle labeling.--
        The labeling for over-the-counter test specimen receptacles for 
        drugs of abuse testing shall bear the name and place of 
        business of the developer included in the registration under 
        section 587J and any information specified in applicable 
        regulations promulgated under this section, in language 
        appropriate for the intended users.
    ``(e) Tests in the Strategic National Stockpile.--
            ``(1) In general.--The Secretary may grant an exception or 
        alternative to any provision listed in this section, unless 
        explicitly required by a statutory provision outside this 
        subchapter, for specified lots, batches, or other units of an 
        in vitro clinical test, if the Secretary determines that 
        compliance with such labeling requirement could adversely 
        affect the availability of such products that are, or will be, 
        included in the Strategic National Stockpile under section 
        319F-2 of the Public Health Service Act.
            ``(2) Regulations.--The Secretary may issue regulations 
        amending section 809.11 of title 21, Code of Federal 
        Regulations (or any successor regulation) to apply in full or 
        in part to in vitro clinical tests and in vitro clinical test 
        developers.
    ``(f) Regulations.--The Secretary shall issue regulations related 
to standardized, general content and format for in vitro clinical test 
labeling pursuant to this subsection.

``SEC. 587M. ADVERSE EVENT REPORTING.

    ``(a) In General.--Each in vitro clinical test developer shall 
establish and maintain a system for establishing and maintaining 
records of adverse events and reporting adverse events in accordance 
with this section.
    ``(b) Submission of Individual Reports.--A developer shall submit 
an individual adverse event report not later than 5 calendar days after 
the developer receives or becomes aware of an adverse event that 
reasonably suggests that an in vitro clinical test may--
            ``(1) have caused or contributed to a patient or user 
        death; or
            ``(2) present an imminent threat to public health.
    ``(c) Submission of Quarterly Reports.--As applicable, a developer 
shall submit quarterly reports that include any in vitro clinical test 
errors and serious injuries that occurred during the applicable 
quarter. Such quarterly reports shall be submitted not later than the 
end of the quarter following the quarter in which the developer 
receives or becomes aware of such adverse events.
    ``(d) Definitions.--For the purposes of this section--
            ``(1) the term `in vitro clinical test error' means a 
        failure of an in vitro clinical test to meet its performance 
        specifications, or to otherwise perform as intended by the 
        developer, including an inaccurate result resulting from such 
        failure; and
            ``(2) the term `serious injury' means--
                    ``(A) a significant delay in a diagnosis that 
                results in the absence, delay, or discontinuation of 
                critical medical treatment or that irreversibly or 
                seriously and negatively alters the course of a disease 
                or condition; or
                    ``(B) an injury that--
                            ``(i) is life threatening;
                            ``(ii) results in permanent impairment of a 
                        body function or permanent damage to a body 
                        structure; or
                            ``(iii) necessitates medical or surgical 
                        intervention to preclude permanent impairment 
                        of a body function or permanent damage to a 
                        body structure.
    ``(e) Regulations.--The Secretary shall promulgate regulations to 
implement this section.

``SEC. 587N. CORRECTIONS AND REMOVALS.

    ``(a) Regulations.--The Secretary shall promulgate regulations, or 
amend existing regulations, as appropriate, to implement this section.
    ``(b) Reports of Corrections and Removals.--
            ``(1) In general.--Each in vitro clinical test developer 
        shall report to the Secretary any correction or removal of an 
        in vitro clinical test undertaken by such developer if the 
        correction or removal was undertaken--
                    ``(A) to reduce the risk to health posed by the in 
                vitro clinical test; or
                    ``(B) to remedy a violation of this Act caused by 
                the in vitro clinical test which may present a risk to 
                health.
            ``(2) Exception for in vitro clinical tests offered under a 
        technology certification order.--For any eligible test offered 
        under a technology certification order under section 587D, a 
        correction and removal report for any correction or removal of 
        an in vitro clinical test should demonstrate that the issue or 
        issues causing the correction or removal do not adversely 
        impact the ability of other in vitro clinical tests offered 
        under the same technology certification order to meet the 
        applicable standard.
    ``(c) Timing.--A developer shall submit any report required under 
this subsection to the Secretary within 15 business days of initiating 
such correction or removal.
    ``(d) Recordkeeping.--A developer of an in vitro clinical test that 
undertakes a correction or removal of an in vitro clinical test which 
is not required to be reported under this subsection shall keep a 
record of such correction or removal.
    ``(e) Recall Communications.--Upon the reporting of a correction or 
removal by the developer--
            ``(1) the Secretary shall classify such correction or 
        removal under this section within 45 calendar days; and
            ``(2) not later than 70 calendar days after the developer 
        or other responsible party notifies the Secretary that it has 
        completed a recall action, the Secretary shall provide the 
        developer or other responsible party with a written statement 
        closing the recall action or stating the reasons the Secretary 
        cannot close the recall at that time.

``SEC. 587O. RESTRICTED IN VITRO CLINICAL TESTS.

    ``(a) Applicability.--
            ``(1) In general.--For the types of in vitro clinical tests 
        described in paragraph (3), the Secretary may require, in 
        issuing an approval of an in vitro clinical test under section 
        587B, granting a technology certification order under section 
        587D, or in issuing a determination under section 587F(a), or 
        by issuing a regulation, that such test, or category of tests, 
        be restricted to sale, distribution, or use upon such 
        conditions as the Secretary may prescribe under paragraph (2).
            ``(2) Conditions.--The Secretary may prescribe conditions 
        under this section, based on available evidence, with respect 
        to an in vitro clinical test described in paragraph (3), that 
        are determined to be needed due to the potential for harmful 
        effect of such test (including any resulting absence, 
        significant delay, or discontinuation of appropriate medical 
        treatment), and are necessary to ensure that the test meets the 
        applicable standard.
            ``(3) In vitro clinical tests subject to restrictions.--The 
        restrictions or conditions authorized under this section may be 
        applied by the Secretary to any high-risk or moderate-risk in 
        vitro clinical test, prescription home-use in vitro clinical 
        test, direct-to-consumer in vitro clinical test, or over-the-
        counter in vitro clinical test.
    ``(b) Labeling and Advertising of a Restricted in Vitro Clinical 
Test.--The labeling and advertising of an in vitro clinical test to 
which restrictions apply under subsection (a) shall bear such 
appropriate statements of the restrictions as the Secretary may 
prescribe in an approval under section 587B, an order under section 
587D, a determination under section 587F(a), or in regulation, as 
applicable.
    ``(c) Device Restrictions.--An in vitro clinical test that was 
offered as a restricted device prior to the date of enactment of this 
subchapter--
            ``(1) shall continue to comply with the applicable 
        restrictions under section 515 or section 520(e) until this 
        subchapter takes effect; and
            ``(2) except for in vitro clinical tests required to meet 
        the requirements of section 809.30 of title 21, Code of Federal 
        Regulations prior to the effective date of this subchapter 
        specified in section 5(a)(1)(A) of the VALID Act of 2023, such 
        restrictions described in paragraph (1) shall be deemed to be 
        restrictions under this subchapter as of such effective date.

``SEC. 587P. APPEALS.

    ``(a) Significant Decision.--
            ``(1) In general.--The Secretary shall--
                    ``(A) maintain a substantive summary of the 
                scientific and regulatory rationale for any significant 
                decision of the Food and Drug Administration pursuant 
                to section 587F, regarding--
                            ``(i) the submission of an application for, 
                        or a review of, an in vitro clinical test under 
                        section 587B or section 587D;
                            ``(ii) an exemption under section 587C; or
                            ``(iii) any requirements for mitigation 
                        measures to an in vitro clinical test or 
                        category of in vitro clinical tests; and
                    ``(B) include in such summaries documentation of 
                significant controversies or differences of opinion and 
                the resolution of such controversies or differences of 
                opinion.
            ``(2) Provision of documentation.--Upon request, the 
        Secretary shall furnish a substantive summary described in 
        paragraph (1) to the person who has made, or is seeking to 
        make, a submission described in such paragraph.
            ``(3) Application of least burdensome requirements.--The 
        substantive summary required under this subsection shall 
        include a brief statement regarding how the least burdensome 
        requirements were considered and applied consistent with 
        section 587AA(c), as applicable.
    ``(b) Review of Significant Decisions.--
            ``(1) Request for supervisory review of significant 
        decision.--A developer may request a supervisory review of the 
        significant decision described in subsection (a)(1). Such 
        review may be conducted at the next supervisory level or higher 
        above the agency official who made the significant decision.
            ``(2) Submission of request.--A developer requesting a 
        supervisory review under paragraph (1) shall submit such 
        request to the Secretary not later than 30 days after the 
        decision for which the review is requested and shall indicate 
        in the request whether such developer seeks an in-person 
        meeting or a teleconference review.
            ``(3) Timeframe.--The Secretary shall schedule an in-person 
        or teleconference review, if so requested, not later than 30 
        days after such request is made. The Secretary shall issue a 
        decision to the developer requesting a review under this 
        subsection not later than 45 days after the request is made 
        under paragraph (1), or, in the case of a developer who 
        requests an in-person meeting or teleconference, 30 days after 
        such meeting or teleconference.
    ``(c) Advisory Panels.--The process established under subsection 
(a) shall permit the appellant to request review by an advisory 
committee established under section 587G when there is a dispute 
involving substantial scientific fact. If an advisory panel meeting is 
held, the Secretary shall make a determination under this subsection 
not later than 45 days after the requested advisory committee meeting 
has concluded.
    ``(d) Least Burdensome Review.--Any developer who has submitted an 
application under section 587B or 587D may request a supervisory review 
of a request for additional information during an evaluation of such 
submission within 60 calendar days of receipt of the additional 
information request from the Secretary.
    ``(e) Availability of All Remedies.--The procedures set forth in 
this section shall be in addition to, and not in lieu of, other 
remedies available to the developer.

``SEC. 587Q. ACCREDITED PERSONS.

    ``(a) In General.--
            ``(1) Authorization.--Beginning on the date of enactment of 
        the VALID Act of 2023, the Secretary shall accredit persons for 
        any of the following purposes:
                    ``(A) Reviewing applications for premarket approval 
                under section 587B and making findings with respect to 
                such applications.
                    ``(B) Reviewing applications for technology 
                certification under section 587D and making 
                recommendations to the Secretary with respect to such 
                applications.
                    ``(C) Conducting inspections as specified in 
                subsection (c) of in vitro clinical test developers and 
                other persons required to register pursuant to section 
                587J.
            ``(2) Persons submitting applications.--A person submitting 
        an application for premarket approval under section 587B or an 
        application for technology certification under section 587D may 
        submit such application to the Secretary or to a person 
        accredited pursuant to subparagraph (A) or (B) of paragraph 
        (1).
    ``(b) Accredited Persons Application Reviews, Findings, and 
Recommendations.--
            ``(1) Requirements for premarket application.--
                    ``(A) Review, finding, and recommendation 
                requirements.--An accredited person receiving an 
                application for premarket approval under section 587B 
                shall either--
                            ``(i) provide to the Secretary, together 
                        with the application for premarket approval 
                        submitted by the applicant, a recommendation 
                        based on a finding that the criteria for 
                        approval of the application under section 
                        587B(e)(2)(A) are met and issue a copy of such 
                        finding to the applicant, which finding shall 
                        plainly state--
                                    ``(I) the basis for the accredited 
                                person's finding that the criteria 
                                under section 587B(e)(2)(A) are met; 
                                and
                                    ``(II) any proposed restrictions, 
                                mitigating measures, or conditions of 
                                approval under section 587B(e)(2)(B), 
                                as applicable; or
                            ``(ii) provide a notification to the 
                        applicant that the accredited person cannot 
                        find that the criteria for approval of the 
                        application under section 587B(e)(2)(A) are met 
                        and the reasons for such decision.
                    ``(B) Requesting missing or clarifying 
                information.--After receipt of an application from an 
                accredited person under this section, the Secretary may 
                request missing or clarifying information from the 
                applicant concerning the application, which the 
                accredited person shall promptly provide.
                    ``(C) Secretary action on recommendation that 
                approval criteria are met.--If the accredited person 
                transmits a recommendation to the Secretary under 
                subparagraph (A)(i), then prior to the date that is 45 
                calendar days after the transmittal date, the Secretary 
                shall consider such recommendation and make a 
                determination to--
                            ``(i) approve the application for premarket 
                        approval under section 587B(e)(2) with 
                        appropriate restrictions, mitigating measures, 
                        or conditions of approval, as applicable; or
                            ``(ii) deny approval of the application by 
                        issuing a written notice that reflects 
                        appropriate management input and concurrence to 
                        the accredited person and the applicant 
                        detailing the scientific basis for the 
                        Secretary's determination that the criteria for 
                        issuance of an approval under section 
                        587B(e)(2)(A) have not been met.
                    ``(D) Effect of inaction on recommendation.--If the 
                Secretary fails to take an action under subparagraph 
                (C) the Secretary shall--
                            ``(i) within 45 calendar days after the 
                        transmittal date, provide written feedback to 
                        the applicant that--
                                    ``(I) includes all outstanding 
                                issues with the application preventing 
                                the Secretary from taking an action 
                                under subparagraph (B);
                                    ``(II) reflects appropriate 
                                management input and concurrence; and
                                    ``(III) includes action items for 
                                the Secretary, the applicant, or both, 
                                as appropriate, with an estimated date 
                                of completion for the Secretary and the 
                                applicant to complete their respective 
                                tasks, as applicable; and
                            ``(ii) promptly schedule a meeting or 
                        teleconference to discuss the feedback provided 
                        under clause (i), unless the Secretary and 
                        applicant agree that the outstanding issues are 
                        adequately presented through written 
                        correspondence and a meeting or teleconference 
                        is not necessary.
            ``(2) Requirements for technology certification.--
                    ``(A) Review and recommendation requirements.--An 
                accredited person receiving an application for 
                technology certification under section 587D shall 
                either--
                            ``(i) provide to the Secretary, together 
                        with the application for technology 
                        certification submitted by the applicant, a 
                        recommendation that the criteria for issuance 
                        of a technology certification order under 
                        section 587D(d)(3) are met and issue a copy of 
                        such recommendation to the applicant, which 
                        recommendation shall plainly state the basis 
                        for the accredited person's recommendation that 
                        the criteria under section 587D(d)(3) are met; 
                        or
                            ``(ii) provide a notification to the 
                        applicant that the accredited person cannot 
                        recommend that the criteria for issuance of a 
                        technology certification order under section 
                        587D(d)(3) are met and the reasons for such 
                        decision.
                    ``(B) Requesting missing or clarifying 
                information.--After receipt of an application under 
                this section, the accredited person may request missing 
                or clarifying information from the applicant concerning 
                the application, which the applicant shall promptly 
                provide.
                    ``(C) Secretary action on recommendation for 
                issuance of a technology certification order.--If the 
                accredited person transmits a recommendation to the 
                Secretary under clause (i) of subparagraph (A), then 
                prior to the date that is 60 calendar days after the 
                transmittal date the Secretary shall--
                            ``(i) issue the technology certification 
                        order under section 587D(d)(3), consistent with 
                        such recommendation from the accredited person; 
                        or
                            ``(ii) deny approval of the application by 
                        issuing a written notice to the accredited 
                        person and the applicant detailing the 
                        scientific basis for a determination by the 
                        Secretary that the criteria for issuance of a 
                        technology certification order under section 
                        587D(d)(3) have not been met.
    ``(c) Requirements for Inspections.--
            ``(1) In general.--When conducting inspection, persons 
        accredited under subsection (a)(1)(C) shall record in writing 
        their specific observations and shall present their 
        observations to the designated representative of the inspected 
        establishment.
            ``(2) Inspection report requirements.--Each person 
        accredited under subsection (a)(1)(C) shall prepare and submit 
        to the Secretary an inspection report in a form and manner 
        designated by the Secretary for conducting inspections. Any 
        statement or representation made by an employee or agent of an 
        establishment to a person accredited to conduct inspections 
        under subsection (a)(1)(C) shall be subject to section 1001 of 
        title 18, United States Code.
            ``(3) Savings clause.--Nothing in this section affects the 
        authority of the Secretary to inspect any in vitro clinical 
        test developer or other person registered under section 587J or 
        recognize inspections conducted by auditing organizations as 
        described under section 704(g)(15).
            ``(4) Inspection limitations.--The Secretary shall ensure 
        that inspections carried out under this section are not 
        duplicative of inspections carried out under section 353 of the 
        Public Health Service Act. Inspections under this section shall 
        be limited to the data and information necessary--
                    ``(A) for routine surveillance activities of 
                facilities associated with an approved application 
                under section 587B or issuance of a technology 
                certification order under section 587D; or
                    ``(B) to meet the requirements for premarket 
                approval under section 587B or issuance of a technology 
                certification order under section 587D, as applicable.
    ``(d) Accreditation.--
            ``(1) Accreditation program.--The Secretary may provide for 
        accreditation under this section through programs administered 
        by the Food and Drug Administration, by other non-Federal 
        government agencies, or by qualified nongovernmental 
        organizations. A person may be accredited for the review of 
        applications submitted under sections 587B as described in 
        subsection (a)(1)(A), for the review of applications submitted 
        under section 587D as described in subsection (a)(1)(B), and to 
        conduct inspection activities under subsection (a)(1)(C), or 
        for a subset of such reviews or activities.
            ``(2) Eligible persons.--
                    ``(A) Minimum qualifications.--An accredited 
                person, at a minimum, shall--
                            ``(i) not be an employee of the Federal 
                        Government;
                            ``(ii) not engage in the activities of a 
                        developer, as defined in section 587(7);
                            ``(iii) not be a person required to 
                        register under section 587J, unless such person 
                        has established sufficient processes and 
                        protocols to separate activities to develop in 
                        vitro clinical tests and the activities for 
                        which such person would be accredited under 
                        subsection (a) and discloses applicable 
                        information under this section;
                            ``(iv) not be owned or controlled by, and 
                        shall have no organizational, material, or 
                        financial affiliation with, an in vitro 
                        clinical test developer or other person 
                        required to register under section 587J;
                            ``(v) be a legally constituted entity 
                        permitted to conduct the activities for which 
                        it seeks accreditation;
                            ``(vi) ensure that the operations of such 
                        person are in accordance with generally 
                        accepted professional and ethical business 
                        practices; and
                            ``(vii) include in its request for 
                        accreditation a commitment to, at the time of 
                        accreditation and at any time it is performing 
                        activities pursuant to this section--
                                    ``(I) certify that the information 
                                reported to the Secretary accurately 
                                reflects the data or protocol reviewed, 
                                and the documented inspection findings, 
                                as applicable;
                                    ``(II) limit work to that for which 
                                competence and capacity are available;
                                    ``(III) treat information received 
                                or learned, records, reports, and 
                                recommendations as proprietary 
                                information of the person submitting 
                                such information; and
                                    ``(IV) in conducting the activities 
                                for which the person is accredited in 
                                respect to a particular in vitro 
                                clinical test, protect against the use 
                                of any employee or consultant who has a 
                                financial conflict of interest 
                                regarding that in vitro clinical test.
                    ``(B) Waiver.--The Secretary may waive any 
                requirements in clause (i), (ii), (iii), or (iv) of 
                subparagraph (A) upon making a determination that such 
                person has implemented other appropriate controls 
                sufficient to ensure a competent and impartial review.
            ``(3) Accreditation process.--
                    ``(A) Accreditation process guidance and 
                regulations.--Not later than 180 days after the date of 
                enactment of the VALID Act of 2023, the Secretary shall 
                issue draft guidance specifying the process for 
                submitting a request for accreditation and 
                reaccreditation under this section, including the form 
                and content of information to be submitted, including 
                the criteria that the Secretary will consider to 
                accredit or deny accreditation and, not later than 1 
                year after the close of the comment period for the 
                draft guidance, issue final guidance.
                    ``(B) Response to request.--The Secretary shall 
                respond to a request for accreditation or 
                reaccreditation within 60 calendar days of the receipt 
                of the request. The Secretary's response may be to 
                accredit or reaccredit the person, to deny 
                accreditation, or to request additional information in 
                support of the request. If the Secretary requests 
                additional information, the Secretary shall respond 
                within 60 calendar days of receipt of such additional 
                information to accredit or deny the accreditation.
                    ``(C) Type of accreditation.--The accreditation or 
                reaccreditation of a person shall specify the 
                particular activity or activities under subsection (a) 
                for which such person is accredited, and shall include 
                any limitation to certain eligible in vitro clinical 
                tests.
                    ``(D) Public list.--The Secretary shall publish on 
                the website of the Food and Drug Administration a list 
                of persons who are accredited under this section. Such 
                list shall be updated on at least a monthly basis. The 
                list shall specify the particular activity or 
                activities under this section for which the person is 
                accredited.
                    ``(E) Audit.--The Secretary may audit the 
                performance of persons accredited under this section 
                for purposes of ensuring that such persons continue to 
                meet the published criteria for accreditation, and may 
                modify the scope or particular activities for which a 
                person is accredited if the Secretary determines that 
                such person fails to meet one or more criteria for 
                accreditation.
                    ``(F) Suspension or withdrawal.--The Secretary may 
                suspend or withdraw accreditation of any person 
                accredited under this section, after providing notice 
                and an opportunity for an informal hearing, when such 
                person is substantially not in compliance with the 
                requirements of this section or the published criteria 
                for accreditation, or poses a threat to public health, 
                or fails to act in a manner that is consistent with the 
                purposes of this section.
                    ``(G) Reaccreditation.--Accredited persons may be 
                initially accredited for up to 3 years. After 
                expiration of such initial period, persons may be 
                reaccredited for unlimited additional 5-year periods, 
                as determined by the Secretary.
    ``(e) Compensation of Accredited Persons.--Compensation of an 
accredited person shall be determined by agreement between the 
accredited person and the person who engages the services of the 
accredited person, and shall be paid by the person who engages such 
services.
    ``(f) International Harmonization.--Notwithstanding any other 
provision of this section, to facilitate international harmonization 
the Secretary may recognize persons accredited or recognized by 
governments, who have also entered into information sharing agreements, 
including confidentiality commitments, with the Commissioner of Food 
and Drugs.
    ``(g) Information Sharing Agreements.--An accredited person may 
enter into an agreement with a test developer to provide information to 
the comprehensive test information system under section 587T, including 
any requirements under section 587J.
    ``(h) Reports.--Not later than 2 years after the effective date of 
the VALID Act of 2023, and annually thereafter for the next 4 years, 
the Secretary shall post on the website of the Food and Drug 
Administration, a report describing the Secretary's performance in 
implementing this section, including the Secretary's progress in 
minimizing duplicative reviews of applications for which an accredited 
person finds the criteria for approval are met. Such reports shall 
include, for each period--
            ``(1) with regard to premarket approval applications--
                    ``(A) the total number of findings transmitted to 
                the Secretary under subsection (b)(1)(A)(i);
                    ``(B) the total number of determinations made by 
                the Secretary under subsection (b)(1)(B)(i) within 30 
                calendar days of the transmittal date to approve an 
                application;
                    ``(C) the total number of determinations made by 
                the Secretary under subsection (b)(1)(B)(ii) within 30 
                calendar days of the transmittal date to deny approval 
                of an application; and
                    ``(D) the total number of applications that were 
                approved and the total number of applications that were 
                denied approval, after the Secretary failed to make a 
                determination within 30 calendar days of the 
                transmittal date under subsection (b)(1)(B); and
            ``(2) with regard to applications for technology 
        certification--
                    ``(A) the total number of recommendations 
                transmitted to the Secretary under subsection 
                (b)(2)(A)(i);
                    ``(B) the total number of determinations made by 
                the Secretary under subsection (b)(2)(B)(i) to issue a 
                technology certification order, including 
                determinations made within 30 days of the transmittal 
                date;
                    ``(C) the total number of determinations made by 
                the Secretary under subsection (b)(2)(B)(ii) to deny 
                the application for technology certification, including 
                determinations made within 30 calendar days of the 
                transmittal date; and
                    ``(D) the total number of technology certification 
                orders issued, and the total number of applications for 
                technology certification that were denied, including 
                applications denied after the Secretary failed to make 
                a determination within 30 calendar days of the 
                transmittal date under subsection (b)(2)(B).

``SEC. 587R. RECOGNIZED STANDARDS.

    ``(a) In General.--The Secretary may recognize all or part of 
appropriate standards established by nationally or internationally 
recognized standards development organizations for which a person may 
submit a declaration of conformity in order to meet a requirement under 
this subchapter to which that standard is applicable. Standards for in 
vitro diagnostic devices previously recognized under section 514(c) 
shall be considered recognized standards under this section. Recognized 
and proposed standards shall be accessible to the public at no charge. 
The application of any such consensus standard shall only apply 
prospectively. The Secretary shall issue regulations establishing the 
criteria and process, for such recognition and adoption.
    ``(b) Amendment Process.--The procedures established in this 
section or in regulation or guidance issued under this section shall 
apply to amendment of an existing standard.

``SEC. 587S. INVESTIGATIONAL USE.

    ``(a) In General.--Subject to the conditions prescribed in 
subsections (c), (d), (e), (f), and (g), an in vitro clinical test for 
investigational use shall be exempt from the requirements of this 
subchapter, other than sections 587A, 587P, 587T, and 587V. The 
Secretary may amend parts 50, 54, and 56 of title 21 of the Code of 
Federal Regulations to apply to in vitro clinical tests to permit the 
investigational use of such tests by experts qualified by scientific 
training and experience.
    ``(b) Regulations.--
            ``(1) In general.--Not later than 3 years after the date of 
        enactment of the VALID Act of 2023, the Secretary shall 
        promulgate regulations to implement this section.
            ``(2) Variation.--The requirements in the regulations 
        promulgated under this section shall take into account 
        variations based on--
                    ``(A) the scope and duration of clinical testing to 
                be conducted under investigation that is the subject of 
                such application;
                    ``(B) the number of human subjects that are to be 
                involved in such testing;
                    ``(C) the need to permit changes to be made to the 
                in vitro clinical test involved during testing 
                conducted in accordance with a plan required under 
                subsection (c)(6); or
                    ``(D) whether the clinical testing of such in vitro 
                clinical test is for the purpose of developing data to 
                obtain approval to offer such test.
    ``(c) Application for Investigational Use.--The following shall 
apply with respect to in vitro clinical tests for investigational use:
            ``(1) Significant risk and other studies.--In the case of 
        an in vitro clinical test the investigational use of which 
        poses a significant risk to the human subject or involves an 
        exception from informed consent for emergency research, a 
        sponsor of an investigation of such a test seeking an 
        investigational use exemption shall submit to the Secretary an 
        investigational use application with respect to the in vitro 
        clinical test in accordance with paragraphs (3) and (4).
            ``(2) Non-significant risk studies.--In the case of an in 
        vitro clinical test, the investigational use of which is not 
        described in paragraph (1)--
                    ``(A) the sponsor of such investigation shall--
                            ``(i) ensure such investigation is 
                        conducted in compliance with an investigational 
                        plan approved by an institutional review 
                        committee and the labeling of the in vitro 
                        clinical test involved clearly and 
                        conspicuously states, `For investigational use 
                        only', as specified in paragraph (4)(A)(ii);
                            ``(ii) ensure each investigator obtains 
                        informed consent as required under part 50, 54, 
                        and 56 of title 21, Code of Federal Regulations 
                        (or any successor regulations), subject to the 
                        exceptions set forth in paragraph (6)(C);
                            ``(iii) establish and maintain records with 
                        respect to all requirements in this 
                        subparagraph;
                            ``(iv) maintain records and make reports as 
                        required by the Secretary pursuant to 
                        regulations issued under subsection (b); and
                            ``(v) ensure that investigators monitor 
                        investigations, maintain records and make 
                        reports as required by the Secretary pursuant 
                        to regulations issued under subsection (b); and
                    ``(B) the sponsor may rely on any exception or 
                exemption described in paragraph (4) or as established 
                by the Secretary in regulations issued under subsection 
                (b).
            ``(3) Application.--An investigational use application 
        shall be submitted in such time and manner and contain such 
        information as the Secretary may require in regulation, and 
        shall include an investigational plan for proposed clinical 
        testing and assurances that the sponsor submitting the 
        application will--
                    ``(A) establish and maintain records relevant to 
                the investigation of such in vitro clinical test; and
                    ``(B) submit to the Secretary annual reports of 
                data obtained as a result of the investigational use of 
                the in vitro clinical test during the period covered by 
                the exemption that the Secretary reasonably determines 
                will enable the Secretary--
                            ``(i) to ensure compliance with the 
                        conditions for the exemption specified in 
                        paragraph (4);
                            ``(ii) to review the progress of the 
                        investigation involved; and
                            ``(iii) to evaluate the ability to meet the 
                        applicable standard.
            ``(4) Conditions for exemption.--An application for an 
        investigational use exemption with respect to a significant 
        risk study shall be granted if each of the following conditions 
        is met:
                    ``(A) The risks to the subjects of the in vitro 
                clinical test are outweighed by the anticipated 
                benefits of the test to the subjects and the importance 
                of the knowledge to be gained, and adequate assurance 
                of informed consent is provided in accordance with 
                paragraphs (6)(B) and (6)(C).
                    ``(B) The proposed labeling for the in vitro 
                clinical test involved clearly and conspicuously states 
                `For investigational use only'.
                    ``(C) Such other requirements the Secretary 
                determines--
                            ``(i) are necessary for the protection of 
                        the public health and safety; and
                            ``(ii) do not unduly delay investigation.
            ``(5) Coordination with investigational new drug 
        applications.--Any requirement for the submission of a report 
        to the Secretary pursuant to an application for an 
        investigational new drug exemption involving an in vitro 
        clinical test shall supersede the reporting requirement under 
        paragraph (3)(B), but only to the extent the requirement with 
        respect to the application for exemption with respect to the 
        drug is duplicative of the reporting requirement under such 
        paragraph.
            ``(6) Investigational plan, procedures, and conditions.--
        With respect to an investigational plan submitted under 
        paragraph (3), the sponsor submitting such plan shall--
                    ``(A) promptly notify the Secretary of the approval 
                or the suspension or termination of the approval of 
                such plan by an institutional review committee;
                    ``(B) in the case of an in vitro clinical test made 
                available to investigators for clinical testing, obtain 
                agreements from each investigator that any testing of 
                the in vitro clinical test involving human subjects 
                will be under such investigator's supervision and in 
                accordance with paragraph (C) and submit such 
                agreements to the Secretary that ensure--
                            ``(i) all investigators will comply with 
                        this section, regulations promulgated or 
                        revised under this section, and applicable 
                        human subjects regulations; and
                            ``(ii) the investigator will ensure that--
                                    ``(I) informed consent is obtained 
                                as required under part 50 of title 21, 
                                Code of Federal Regulations (or any 
                                successor regulations), amended to 
                                apply to in vitro clinical tests; and
                                    ``(II) the requirements for 
                                institutional review board under part 
                                56 of title 21 of the Code of Federal 
                                Regulations (or successor regulations), 
                                amended to apply to in vitro clinical 
                                tests, are met; and
                    ``(C) ensure that informed consent will be obtained 
                from each human subject (or the representative of such 
                subject) of proposed clinical testing involving such in 
                vitro clinical test, except where, subject to such 
                other conditions as the Secretary may prescribe--
                            ``(i) the proposed clinical testing poses 
                        no more than minimal risk to the human subject 
                        and includes appropriate safeguards to protect 
                        the rights, safety, and welfare of the human 
                        subject; or
                            ``(ii) the investigator conducting or 
                        supervising the clinical testing determines in 
                        writing that there exists a life-threatening 
                        situation involving the human subject of such 
                        testing which necessitates the use of such in 
                        vitro clinical test and it is not feasible to 
                        obtain informed consent from the subject and 
                        there is not sufficient time to obtain such 
                        consent from a representative of such subject.
            ``(7) Concurred by licensed physician.--The determination 
        required by paragraph (6)(C)(ii) shall be concurred in writing 
        by a licensed physician who is not involved in the testing of 
        the human subject with respect to which such determination is 
        made unless immediate use of the in vitro clinical test is 
        required to save the life of the human subject of such testing 
        and there is not sufficient time to obtain such concurrence.
            ``(8) Significant risk.--For purposes of this subsection, 
        the term `significant risk' means, with respect to an in vitro 
        clinical test, that the use of such in vitro clinical test--
                    ``(A) is of substantial importance in performing an 
                activity or activities described in section 201(ss)(1) 
                for, a serious or life-threatening disease or condition 
                without confirmation of the diagnosis by a medically 
                established diagnostic product or procedure;
                    ``(B) requires an invasive sampling procedure that 
                presents a significant risk to the human subject, 
                provided that routine venipuncture shall not be 
                considered an invasive sampling procedure; or
                    ``(C) otherwise presents a potential for serious 
                risk to the health of a human subject.
    ``(d) Review of Applications.--
            ``(1) In general.--The Secretary may issue an order 
        approving an investigation as proposed, approving it with 
        conditions or modifications, or disapproving it.
            ``(2) Failure to act.--Unless the Secretary, not later than 
        30 calendar days after the date of the submission of an 
        application for an investigational use exemption that meets the 
        requirements of subsection (c), issues an order under paragraph 
        (1) and notifies the sponsor submitting the application, the 
        application shall be treated as approved as of such date 
        without further action by the Secretary.
            ``(3) Denial.--The Secretary may deny an investigational 
        use application submitted under this subsection if the 
        Secretary determines that the investigation with respect to 
        which the application is submitted does not conform to the 
        requirements of subsection (c). A notification of such denial 
        submitted to the sponsor with respect to such a request shall 
        contain the order of disapproval and a complete statement of 
        the reasons for the Secretary's denial of the application.
    ``(e) Withdrawal of Exemption.--
            ``(1) In general.--The Secretary may, by administrative 
        order, withdraw an exemption approved under this section with 
        respect to an in vitro clinical test, including an exemption 
        treated as approved based on the Secretary's failure to act 
        pursuant to subsection (d)(2), if the Secretary determines that 
        an investigation conducted under such an exemption does not 
        meet the applicable conditions under subsection (c)(3) for such 
        exemption.
            ``(2) Opportunity to be heard.--
                    ``(A) In general.--Subject to subparagraph (B), an 
                order withdrawing an investigational use exemption 
                granted under this section may be issued only after the 
                Secretary provides the sponsor of the in vitro clinical 
                test with an opportunity for an informal hearing.
                    ``(B) Exception.--An order referred to in 
                subparagraph (A) with respect to an investigational use 
                exemption granted under this section may be issued on a 
                preliminary basis before the provision of an 
                opportunity for an informal hearing if the Secretary 
                determines that the continuation of testing under the 
                exemption will result in an unreasonable risk to the 
                public health. The Secretary will provide an 
                opportunity for an informal hearing promptly following 
                any preliminary action under this subparagraph.
    ``(f) Changes.--
            ``(1) In general.--The regulations promulgated under 
        subsection (b) shall provide, with respect to an in vitro 
        clinical test for which an exemption under this subsection is 
        in effect, procedures and conditions under which changes are 
        allowed without the additional approval of an application for 
        an exemption or submission of a supplement to such an 
        application. Such regulations shall provide that such a change 
        may be made if--
                    ``(A) the sponsor determines, on the basis of 
                credible information (as defined in regulations) that 
                the change meets the conditions specified in paragraph 
                (2); and
                    ``(B) the sponsor submits to the Secretary, not 
                later than 5 calendar days after making the change, a 
                notice of the change.
            ``(2) Conditions.--The conditions specified in this 
        paragraph are that--
                    ``(A) in the case of developmental changes to an in 
                vitro clinical test, including manufacturing changes, 
                the changes--
                            ``(i) do not constitute a significant 
                        change in design or in basic principles of 
                        operation;
                            ``(ii) do not affect the rights, safety, or 
                        welfare of the human subjects involved in the 
                        investigation; and
                            ``(iii) are made in response to information 
                        gathered during the course of an investigation; 
                        and
                    ``(B) in the case of changes to clinical protocols 
                applicable to the test, the changes do not affect--
                            ``(i) the validity of data or information 
                        resulting from the completion of an approved 
                        clinical protocol, or the relationship of 
                        likely patient risk to benefit relied upon to 
                        approve a product;
                            ``(ii) the scientific soundness of a plan 
                        submitted under subsection (c)(3); or
                            ``(iii) the rights, safety, or welfare of 
                        the human subjects involved in the 
                        investigation.
    ``(g) Clinical Hold.--
            ``(1) In general.--At any time, the Secretary may impose a 
        clinical hold with respect to an investigation of an in vitro 
        clinical test if the Secretary makes a written determination 
        described in paragraph (2). The Secretary shall, in imposing 
        such clinical hold, specify the basis for the clinical hold, 
        including the specific information available to the Secretary 
        which served as the basis for such clinical hold, and confirm 
        such determination in writing. The applicant may immediately 
        appeal any such determination pursuant to section 587P.
            ``(2) Determination.--
                    ``(A) In general.--For purposes of paragraph (1), a 
                determination described in this subparagraph with 
                respect to a clinical hold is a determination that, 
                based on credible evidence, the in vitro clinical test 
                involved represents an unreasonable risk to the safety 
                of the persons who are the subjects of the clinical 
                investigation, taking into account the qualifications 
                of the clinical investigators, information about the in 
                vitro clinical test, the design of the clinical 
                investigation, the condition for which the in vitro 
                clinical test is to be investigated, and the health 
                status of the subjects involved.
                    ``(B) Removal of clinical hold.--Any written 
                request to the Secretary from the sponsor of an 
                investigation that a clinical hold be removed shall 
                receive a decision, in writing and specifying the 
                reasons therefor, within 30 days after receipt of such 
                request. Any such request shall include sufficient 
                information to support the removal of such clinical 
                hold.

``SEC. 587T. COMPREHENSIVE TEST INFORMATION SYSTEM.

    ``(a) Establishment.--Not later than 2 years after the date of 
enactment of the VALID Act of 2023, the Secretary shall make available 
a comprehensive test information system for in vitro clinical tests 
that is designed to--
            ``(1) provide a transparent interface on the website of the 
        Food and Drug Administration for stakeholders, to the extent 
        permitted by applicable law, which may include access to the--
                    ``(A) regulatory pathway designation information 
                for each in vitro clinical test or tests with the same 
                indications for use;
                    ``(B) registration and listing information provided 
                by developers under section 587J, including the use of 
                a link for labels;
                    ``(C) adverse event reports submitted under section 
                587M, as appropriate;
                    ``(D) reports of corrections and removals submitted 
                under section 587N; and
                    ``(E) other information pertaining to an in vitro 
                clinical test or tests with the same indications for 
                use, as the Secretary determines appropriate; and
            ``(2) provide a secure portal for electronic submission, 
        including applications and other in vitro clinical test 
        submissions, registration and listing information, and adverse 
        event reports, which provides protections from unauthorized 
        disclosure of information, including of--
                    ``(A) trade secret or confidential commercial or 
                financial information; and
                    ``(B) information that could compromise national 
                security.
    ``(b) Submission Function.--The comprehensive test information 
system shall serve as the electronic submission service for test 
developers submitting information for applications under sections 587B 
and 587D.

``SEC. 587U. PREEMPTION.

    ``(a) In General.--Except as provided in subsection (b), no State, 
Tribal, or local government (or political subdivision thereof) may 
establish or continue in effect any requirement--
            ``(1) that is different from, or in addition to, any 
        requirement applicable to an in vitro clinical test under this 
        Act; or
            ``(2) with respect to the analytical validity, clinical 
        validity, or safety for individuals who come into contact with 
        such an in vitro clinical test.
    ``(b) Exceptions.--Subsection (a) shall not be construed to affect 
the authority of a State, Tribal, or local government to do any of the 
following:
            ``(1) To license laboratory personnel, health care 
        practitioners, or health care facilities or to regulate any 
        aspect of a health care practitioner-patient relationship.
            ``(2) To enforce laws of general applicability, such as 
        zoning laws, environmental laws, labor laws, and general 
        business laws.
            ``(3) To authorize laboratories to develop and perform an 
        in vitro clinical test, pursuant to a law enacted by a State 
        prior to January 1, 2022, as long as such law does not impose 
        requirements that are different from any requirement applicable 
        to an in vitro clinical test under this Act. If a State has 
        enacted such a law, the Secretary shall exempt such test for 
        laboratories in that State from compliance with this 
        subchapter.
    ``(c) Clarification.--Nothing in this section shall be construed 
to--
            ``(1) modify any action for damages or the liability of any 
        person under the law of any State; or
            ``(2) shift liability to health care practitioners or other 
        users.

``SEC. 587V. ADULTERATION.

    ``An in vitro clinical test shall be deemed to be adulterated:
            ``(1) If it consists in whole or in part of any filthy, 
        putrid, or decomposed substance.
            ``(2) If it has been developed, prepared, packed, or held 
        under insanitary conditions whereby it may have been 
        contaminated with filth, or whereby it may have been rendered 
        injurious to health.
            ``(3) If its container or package is composed, in whole or 
        in part, of any poisonous or deleterious substance which may 
        render the contents injurious to health.
            ``(4) If it bears or contains, for purposes of coloring 
        only, a color additive which is unsafe within the meaning of 
        section 721(a).
            ``(5) If its analytical or clinical validity, as 
        applicable, or with respect to a specimen receptacle, its 
        safety, falls below that which it purports or is represented to 
        possess.
            ``(6) If it is required to be, declared to be, purports to 
        be, or is represented as being, in conformity with any 
        performance standard established or recognized under section 
        587R and is not in conformity with such standard.
            ``(7) If it is required to be in compliance with mitigating 
        measures established under section 587E and is not in 
        conformity with such mitigating measures.
            ``(8) If it fails to have in effect an approved premarket 
        application under section 587B, unless such in vitro clinical 
        test is in compliance with the requirements for--
                    ``(A) offering without an approved premarket 
                application under section 587D(b)(1);
                    ``(B) an exemption from premarket approval under 
                section 587C or 587G; or
                    ``(C) investigational use pursuant to section 587S.
            ``(9) If it is not in conformity with any condition 
        established under section 587B or 587D.
            ``(10) If it purports to be an in vitro clinical test 
        subject to an exemption under section 587C and it fails to meet 
        or maintain any criteria, condition, or requirement of such 
        exemption.
            ``(11) If it has been granted an exemption under section 
        587S for investigational use, and the person granted such 
        exemption or any investigator who uses such in vitro clinical 
        test under such exemption fails to comply with a requirement 
        prescribed by or under such section.
            ``(12) If it fails to meet the quality requirements 
        prescribed in or established under section 587K (as 
        applicable), or the methods used in, or facilities or controls 
        used for, its development, packaging, storage, or installation 
        are not in conformity with applicable requirements established 
        under such section.
            ``(13) If it has been developed, processed, packaged, or 
        held in any establishment, factory, or warehouse and the owner, 
        operator or agent of such establishment, factory, or warehouse 
        delays, denies, or limits an inspection, or refuses to permit 
        entry or inspection.
            ``(14) If it is not in compliance with any restriction 
        required under section 587O.

``SEC. 587W. MISBRANDING.

    ``An in vitro clinical test shall be deemed to be misbranded:
            ``(1) If its labeling is false or misleading in any 
        particular.
            ``(2) If in a package form unless it bears a label 
        containing--
                    ``(A) the name and place of business of the test 
                developer, packager, or distributor; and
                    ``(B) an accurate statement of the quantity of 
                contents in terms of weight, measure, or numerical 
                count, unless an exemption is granted by the Secretary 
                by the issuance of guidance, such as with respect to 
                small packages.
            ``(3) If any word, statement, or other information required 
        by or under authority of this Act to appear on the label or 
        labeling, including a test report, is not prominently placed 
        thereon with such conspicuousness (as compared with other 
        words, statements, designs, or devices, in the labeling) and in 
        such terms as to render it likely to be read and understood by 
        the ordinary individual under customary conditions of purchase 
        and use.
            ``(4) Unless its labeling bears adequate directions for use 
        and such adequate warnings as are necessary for the protection 
        of users of the in vitro clinical test and recipients of the 
        results of such in vitro clinical test, including patients, 
        consumers, donors, and related health care professionals. 
        Required labeling for in vitro clinical tests intended for use 
        in health care facilities, blood establishments, or by a health 
        care professional may be made available solely by electronic 
        means, provided that the labeling complies with all applicable 
        requirements of law, and that the test developer, or 
        distributor affords such users the opportunity to request the 
        labeling in paper form, and after such request, promptly 
        provides the requested information without additional cost.
            ``(5) If there is a reasonable probability that it could 
        cause serious or adverse health consequences or death, 
        including through absence, delay, or discontinuation in 
        diagnosis or treatment, when used in the manner prescribed, 
        recommended, or suggested in the labeling thereof.
            ``(6) If it was developed, sterilized, packaged, 
        repackaged, relabeled, installed, or imported in an 
        establishment not duly registered under section 587J or it was 
        not included in a listing under section 587J, in accordance 
        with timely reporting requirements under this subchapter.
            ``(7) In the case of any in vitro clinical test subject to 
        restrictions under section 587O, (1) if its advertising is 
        false or misleading in any particular, (2) if it is offered for 
        clinical use, sold, distributed, or used in violation of such 
        restrictions, or (3) unless the test developer or distributor 
        includes in all advertisements and other descriptive printed 
        matter that such person issues or causes to be issued, a brief 
        statement of the indications for use of the in vitro clinical 
        test and relevant warnings, precautions, side effects, and 
        contraindications. This paragraph shall not be applicable to 
        any printed matter that the Secretary determines to be labeling 
        as defined in section 201(m).
            ``(8) If it is subject to a mitigating measure established 
        under section 587E and does not bear such labeling as may be 
        prescribed in such mitigating measure.
            ``(9) If it is subject to a standard established under 
        section 587R and it does not bear such labeling as may be 
        prescribed in such standard.
            ``(10) Unless it bears such labeling as may be required by 
        or established under an applicable labeling requirement under 
        this Act.
            ``(11) If there was a failure to comply with any 
        requirement prescribed in or under section 587D, 587J, 587K, 
        587L, 587M, 587N, 587X, 587Y, 587Z, or to provide any report, 
        material, or other information required with respect to in 
        vitro clinical tests under this subchapter.

``SEC. 587X. POSTMARKET SURVEILLANCE.

    ``(a) In General.--
            ``(1) In general.--In addition to other applicable 
        requirements under this Act, the Secretary may issue an order 
        requiring a developer of a high-risk or moderate-risk in vitro 
        clinical test to conduct postmarket surveillance of such in 
        vitro clinical test, if the failure of the in vitro clinical 
        test is reasonably likely to result in serious adverse health 
        consequences or death from use of such in vitro clinical test.
            ``(2) Consideration.--In determining whether to require a 
        developer to conduct postmarket surveillance of an in vitro 
        clinical test, the Secretary shall take into consideration the 
        benefits and risks for the patient and the least burdensome 
        requirements under section 587AA(c).
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each developer required to conduct 
        surveillance of an in vitro clinical test shall submit, within 
        30 days of receiving an order from the Secretary, a plan for 
        the required surveillance. The Secretary, within 60 days of the 
        receipt of such plan, shall determine if the person designated 
        to conduct the surveillance has the appropriate qualifications 
        and experience to undertake such surveillance and if the plan 
        will result in useful data that can reveal unforeseen adverse 
        events or other information necessary to protect the health of 
        patients or the public.
            ``(2) Timeline.--The developer shall commence surveillance 
        under this section not later than 15 months after the day on 
        which the Secretary orders such postmarket surveillance, unless 
        the Secretary determines more time is needed to commence 
        surveillance.
            ``(3) Prospective surveillance.--The Secretary may order a 
        prospective surveillance period of up to 3 years. Any 
        determination by the Secretary that a longer period is 
        necessary shall be made by mutual agreement between the 
        Secretary and the developer or, if no agreement can be reached, 
        upon the completion of a dispute resolution process pursuant to 
        section 562.

``SEC. 587Y. ELECTRONIC FORMAT FOR SUBMISSIONS.

    ``(a) In General.--All submissions to the Food and Drug 
Administration with respect to an in vitro clinical test, unless 
otherwise agreed to by the Secretary, shall--
            ``(1) be made electronically; and
            ``(2) with respect to the information required under 
        sections 587B and 587D, utilize the system described in section 
        587T.
    ``(b) Electronic Format.--Beginning on such date as the Secretary 
specifies in final guidance issued under subsection (c), submissions 
for in vitro clinical tests, including recommendations submitted by 
accredited and recognized persons under section 587Q, and any appeals 
of action taken by the Secretary with respect to such submissions, 
shall be submitted in such electronic format as specified by the 
Secretary in such guidance.
    ``(c) Guidance.--The Secretary shall issue guidance implementing 
this section. Such guidance may--
            ``(1) provide standards for the electronic submission 
        required under subsection (a) or the submission in electronic 
        format required under subsection (b);
            ``(2) set forth criteria for waivers of, or exemptions 
        from, the requirements of subsection (a) or (b); and
            ``(3) provide any other information for the efficient 
        implementation and enforcement of this section.

``SEC. 587Z. POSTMARKET REMEDIES.

    ``(a) Safety Notice.--
            ``(1) In general.--If the Secretary determines that an in 
        vitro clinical test presents an unreasonable risk of 
        substantial harm to the public health, and notification under 
        this subsection is necessary to eliminate the unreasonable risk 
        of such harm and no more practicable means is available under 
        the provisions of this Act (other than this section) to 
        eliminate the risk, the Secretary may issue such order as may 
        be necessary to ensure that adequate safety notice is provided 
        in an appropriate form, by the persons and means best suited 
        under the circumstances, to all health care professionals who 
        prescribe, order, or use the in vitro clinical test and to any 
        other person (including developers, importers, distributors, 
        retailers, and users) who should properly receive such notice.
            ``(2) Notice to individuals.--An order under this 
        subsection shall require that the individuals subject to the 
        risk with respect to which the order is to be issued be 
        included in the persons to be notified of the risk unless the 
        Secretary determines that notice to such individuals would 
        present a greater danger to the health of such individuals than 
        no such notice. If the Secretary makes such a determination 
        with respect to such individuals, the order shall require the 
        health care professionals who prescribed, ordered, or used the 
        in vitro clinical test provide notification to the individuals 
        for whom the health professionals prescribed, ordered, or used 
        such test, of the risk presented by such in vitro clinical test 
        and of any action which may be taken by or on behalf of such 
        individuals to eliminate or reduce such risk. Before issuing an 
        order under this subsection, the Secretary shall consult with 
        the persons required to give notice under the order.
    ``(b) Repair, Replacement, or Refund.--
            ``(1) Determination after an informal hearing.--
                    ``(A) In general.--If, after affording opportunity 
                for an informal hearing, the Secretary determines 
                that--
                            ``(i) an in vitro clinical test presents an 
                        unreasonable risk of substantial harm to the 
                        public health;
                            ``(ii) there are reasonable grounds to 
                        believe that the in vitro clinical test was not 
                        properly developed or manufactured considering 
                        the state of the art as it existed at the time 
                        of its development;
                            ``(iii) there are reasonable grounds to 
                        believe that the unreasonable risk was not 
                        caused by failure of a person other than a 
                        developer, importer, distributor, or retailer 
                        of the in vitro clinical test to exercise due 
                        care in the installation, maintenance, repair, 
                        or use of the in vitro clinical test; and
                            ``(iv) the notice authorized by subsection 
                        (a) would not by itself be sufficient to 
                        eliminate the unreasonable risk and action 
                        described in paragraph (2) of this subsection 
                        is necessary to eliminate such risk,
                the Secretary may order the developer, importer, or any 
                distributor of such in vitro clinical test, or any 
                combination of such persons, to submit to him within a 
                reasonable time a plan for taking one or more of the 
                actions described in paragraph (2). An order issued 
                under the preceding sentence which is directed to more 
                than one person shall specify which person may decide 
                which action shall be taken under such plan and the 
                person specified shall be the person who the Secretary 
                determines bears the principal, ultimate financial 
                responsibility for action taken under the plan unless 
                the Secretary cannot determine who bears such 
                responsibility or the Secretary determines that the 
                protection of the public health requires that such 
                decision be made by a person (including a health 
                professional or user of the in vitro clinical test) 
                other than the person the Secretary determines bears 
                such responsibility.
                    ``(B) Secretary approval of plan.--The Secretary 
                shall approve a plan submitted pursuant to an order 
                issued under subparagraph (A) unless the Secretary 
                determines (after affording opportunity for an informal 
                hearing) that the action or actions to be taken under 
                the plan or the manner in which such action or actions 
                are to be taken under the plan will not assure that the 
                unreasonable risk with respect to which such order was 
                issued will be eliminated. If the Secretary disapproves 
                a plan, the Secretary shall order a revised plan to be 
                submitted within a reasonable time. If the Secretary 
                determines (after affording opportunity for an informal 
                hearing) that the revised plan is unsatisfactory or if 
                no revised plan or no initial plan has been submitted 
                to the Secretary within the prescribed time, the 
                Secretary shall--
                            ``(i) prescribe a plan to be carried out by 
                        the person or persons to whom the order issued 
                        under subparagraph (A) was directed; or
                            ``(ii) after affording an opportunity for 
                        an informal hearing, by order prescribe a plan 
                        to be carried out by a person who is a 
                        developer, importer, distributor, or retailer 
                        of the in vitro clinical test with respect to 
                        which the order was issued but to whom the 
                        order under subparagraph (A) was not directed.
            ``(2) Actions on a plan.--The actions that may be taken 
        under a plan submitted under an order issued under paragraph 
        (1)(A) are as follows:
                    ``(A) To repair the in vitro clinical test so that 
                it does not present the unreasonable risk of 
                substantial harm with respect to which the order under 
                paragraph (1)(A) was issued.
                    ``(B) To replace the in vitro clinical test with a 
                like or equivalent test which is in conformity with all 
                applicable requirements of this Act.
                    ``(C) To refund the purchase price of the in vitro 
                clinical test (less a reasonable allowance for use if 
                such in vitro clinical test has been in the possession 
                of the user for one year or more at the time of notice 
                ordered under subsection (a), or at the time the user 
                receives actual notice of the unreasonable risk with 
                respect to which the order was issued under paragraph 
                (1)(A), whichever occurs first).
            ``(3) No charge.--No charge shall be made to any person 
        (other than a developer, importer, distributor, or retailer) 
        for using a remedy described in paragraph (2) and provided 
        under an order issued under paragraph (1), and the person 
        subject to the order shall reimburse each person (other than a 
        developer, manufacturer, importer, distributor, or retailer) 
        who is entitled to such a remedy for any reasonable and 
        foreseeable expenses actually incurred by such person in using 
        such remedy.
    ``(c) Reimbursement.--An order issued under subsection (b)(1)(A) 
with respect to an in vitro clinical test may require any person who is 
a developer, importer, distributor, or retailer of the in vitro 
clinical test to reimburse any other person who is a developer, 
importer, distributor, or retailer of such in vitro clinical test for 
such other person's expenses actually incurred in connection with 
carrying out the order if the Secretary determines such reimbursement 
is required for the protection of the public health. Any such 
requirement shall not affect any rights or obligations under any 
contract to which the person receiving reimbursement or the person 
making such reimbursement is a party.
    ``(d) Recall Authority.--
            ``(1) In general.--If the Secretary finds that there is a 
        reasonable probability that an in vitro clinical test approved 
        under section 587B or offered under a technology certification 
        order under section 587D would cause serious, adverse health 
        consequences or death, including by the absence, significant 
        delay, or discontinuation of appropriate medical treatment, the 
        Secretary shall issue an order requiring the appropriate person 
        (including the developers, importers, distributors, or 
        retailers of the in vitro clinical test)--
                    ``(A) to immediately cease distribution of such in 
                vitro clinical test; and
                    ``(B) to immediately notify health professionals 
                and applicable in vitro clinical test user facilities 
                of the order and to instruct such professionals and 
                facilities to cease use of such in vitro clinical test.
            ``(2) Informal hearing.--The order issued under paragraph 
        (1)(A), shall provide the person subject to the order with an 
        opportunity for an informal hearing, to be held not later than 
        10 calendar days after the date of the issuance of the order, 
        on the actions required by the order and on whether the order 
        should be amended to require a recall of such in vitro clinical 
        test. If, after providing an opportunity for such a hearing, 
        the Secretary determines that inadequate grounds exist to 
        support the actions required by the order, the Secretary shall 
        vacate the order.
            ``(3) Amended order.--
                    ``(A) In general.--If, after providing an 
                opportunity for an informal hearing under paragraph 
                (2), the Secretary determines that the order should be 
                amended to include a recall of the in vitro clinical 
                test with respect to which the order was issued, the 
                Secretary shall, except as provided in subparagraph 
                (B), amend the order to require a recall. The Secretary 
                shall specify a timetable in which the recall will 
                occur and shall require periodic reports describing the 
                progress of the recall.
                    ``(B) Requirements.--An amended order under 
                subparagraph (A)--
                            ``(i) shall not include recall of the in 
                        vitro clinical test from individuals;
                            ``(ii) shall not include recall of an in 
                        vitro clinical test from test user facilities 
                        if the Secretary determines that the risk of 
                        recalling such in vitro clinical test from the 
                        facilities presents a greater health risk than 
                        the health risk of not recalling the in vitro 
                        clinical test from use; and
                            ``(iii) shall provide for notice to 
                        individuals subject to the risks associated 
                        with the use of such in vitro clinical test. In 
                        providing the notice required by this clause, 
                        the Secretary may use the assistance of health 
                        professionals who prescribed, ordered, or used 
                        such an in vitro clinical test for individuals.
            ``(4) Clarification.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsections (a), (b), and (c).

``SEC. 587AA. APPLICABILITY.

    ``(a) In General.--An in vitro clinical test shall be subject to 
the requirements of this subchapter, except as otherwise provided in 
this subchapter. Laboratory operations shall not be subject to the 
requirements of this subchapter.
    ``(b) Interstate Commerce.--Any in vitro clinical test that is 
offered, including by making available for clinical use in the United 
States is deemed to be an act that constitutes introduction into 
interstate commerce for purposes of enforcing the requirements of this 
Act.
    ``(c) Least Burdensome Requirements.--
            ``(1) In general.--In carrying out this subchapter, the 
        Secretary shall consider the least burdensome means necessary 
        to meet the applicable standard, and other regulatory 
        requirements, as determined by the Secretary.
            ``(2) Necessary defined.--For purposes of paragraph (1), 
        the term `necessary' means the minimum required information 
        that would support a determination by the Secretary that the 
        application meet the applicable standard or regulatory 
        requirement, as determined by the Secretary.
    ``(d) Service of Orders.--Orders of the Secretary under this 
section with respect to applications under subsection (a) or (b) of 
section 587B or supplements under subsection (f) of such section shall 
be served--
            ``(1) in person by any officer or employee of the 
        Department of Health and Human Services designated by the 
        Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail or electronic equivalent addressed to the applicant at the 
        last known address in the records of the Secretary.
    ``(e) Laboratories and Blood and Tissue Establishments.--
            ``(1) Relation to laboratory certification pursuant to 
        section 353 of the public health service act.--Nothing in this 
        subchapter shall be construed to modify the authority of the 
        Secretary with respect to laboratories or clinical laboratories 
        under section 353 of the Public Health Service Act.
            ``(2) Avoiding duplication.--In implementing this 
        subchapter, the Secretary shall avoid issuing or enforcing 
        regulations or guidance that are duplicative of regulations or 
        guidance under section 353 of the Public Health Service Act 
        such that laboratories would be subject to conflicting 
        regulatory obligations with respect to the same activity.
            ``(3) Blood and tissue.--Nothing in this subchapter shall 
        be construed to modify the authority of the Secretary with 
        respect to laboratories, establishments, or other facilities to 
        the extent they are engaged in the propagation, manufacture, or 
        preparation, including filling, labeling, packaging, and 
        storage, of blood, blood components, human cells, tissues, or 
        tissue products pursuant to any requirements under this Act or 
        section 351 or 361 of the Public Health Service Act.
    ``(f) Not Combination Product.--
            ``(1) In general.--A product constituted of a device and an 
        in vitro clinical test is not a combination product and may be 
        regulated as a device or as a device and in vitro clinical 
        test, notwithstanding section 201(ss)(3).
            ``(2) Guidance.--Not later than October 1, 2026, the 
        Secretary shall issue final guidance, after an opportunity for 
        public comment, addressing the considerations for regulating a 
        product described in paragraph (1). Such guidance shall take 
        into account the least burdensome requirements under subsection 
        (c).
    ``(g) Practice of Medicine.--Nothing in this subchapter shall be 
construed to limit or interfere with the authority of a health care 
practitioner to prescribe or administer any lawfully offered in vitro 
clinical test for any condition or disease within a legitimate health 
care practitioner-patient relationship pursuant to applicable Federal 
or State law.
    ``(h) Sale, Distribution, Labeling.--Nothing in this section shall 
be construed to limit the authority of the Secretary to establish or 
enforce restrictions on the sale, distribution, or labeling of an in 
vitro clinical test under this Act.
    ``(i) Promotion of Unapproved Uses.--Nothing in this section shall 
be construed to alter any prohibition on the promotion of unapproved 
uses of legally offered in vitro clinical tests.
    ``(j) Voluntary Submissions.--Nothing in section 587C shall be 
construed to prevent a developer developing a test described in such 
section, including an academic medical center laboratory described in 
subsection (a)(7) of such section, from filing an application under 
section 587B or section 587D, or from adhering to the requirements of 
section 587K with regard to a test protocol described in section 587K 
or for any other test or use of a test.

``SEC. 587BB. JUDICIAL REVIEW.

    ``(a) In General.--Not later than 30 days after an order issued 
pursuant to section 587B or 587D, any person adversely affected by such 
order may file a petition with the United States Court of Appeals for 
the District of Columbia or for the circuit wherein such person resides 
or has a principal place of business for judicial review of such order, 
in accordance with the procedure set forth in section 517(a).
    ``(b) Application of Provisions.--Subsections (a) through (e) of 
section 517 shall apply with respect to a petition under subsection (a) 
of this section in the same manner such subsections apply to a petition 
under section 517. Subsection (f) of section 517 shall apply to an 
order issued under section 587B or 587D.''.

SEC. 4. ENFORCEMENT AND OTHER PROVISIONS.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), (r), 
        and (y), by inserting ``in vitro clinical test,'' after 
        ``device,'' each place it appears;
            (2) in paragraph (g), by inserting after ``misbranded'' the 
        following: ``, and the development within any Territory of any 
        in vitro clinical test that is adulterated or misbranded'';
            (3) in paragraph (y), by inserting ``or 587Q'' after 
        ``section 523'' each place it appears;
            (4) in paragraph (ff), by striking ``or device'' and 
        inserting ``, device, or in vitro clinical test''; and
            (5) by adding at the end, the following:
    ``(fff)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp, tag, 
label, or other identification upon any in vitro clinical test or 
container, packaging, or labeling thereof so as to render such in vitro 
clinical test a counterfeit in vitro clinical test.
    ``(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other thing designed to print, imprint, or reproduce the trademark, 
trade name, or other identifying mark or imprint of another or any 
likeness of any of the foregoing upon any in vitro clinical test or 
container, packaging, or labeling thereof so as to render such in vitro 
clinical test a counterfeit in vitro clinical test.
    ``(3) The doing of any act which causes an in vitro clinical test 
to be a counterfeit in vitro clinical test, or the sale or dispensing, 
or the holding for sale or dispensing, of a counterfeit in vitro 
clinical test.
    ``(ggg)(1) The introduction or delivery for introduction into 
interstate commerce of an in vitro clinical test in violation of 
section 587A(a).
    ``(2) The making of a false, fraudulent, or deceptive statement 
about an in vitro clinical test that is exempt from premarket review 
under section 587C.
    ``(3) The failure to maintain complete and accurate documentation 
for an exemption as required under section 587C or the failure to 
provide labeling required under section 587L.
    ``(4) With respect to an in vitro clinical test, the submission of 
any application, report, or listing under this Act that is false or 
misleading in any material respect.
    ``(5) The failure to comply with a condition of approval, or 
restriction required under an approved application under section 587B; 
the failure to perform a risk analysis required by section 587B; the 
failure to submit an annual update required under section 
587J(c)(2)(B); or the failure to complete postmarket surveillance as 
required under section 587X.
    ``(6) The failure to comply with applicable requirements to submit 
an application or report under section 587D(e).
    ``(7) The failure to comply with applicable mitigating measures 
established under section 587E or to submit, maintain, or make 
available the documentation required under section 587E(b); or the 
failure to comply with applicable performance standards established 
under section 587R.
    ``(8) The failure to register in accordance with section 587J, the 
failure to provide information required under section 587J(b), or the 
failure to maintain or submit information required under section 
587J(c).
    ``(9) The failure to comply with requirements under section 587M or 
587N, the failure to comply with a restriction required under section 
587O, or the failure to comply with labeling and advertising 
requirements under section 587O(b).
    ``(10) The failure to comply with the requirements of section 587Q.
    ``(11) The failure to comply with any requirement of section 587S; 
the failure to furnish any notification, information, material, or 
report required under section 587S; or the failure to comply with an 
order issued under section 587S.
    ``(12) The failure to furnish information requested by the 
Secretary under 587G(d)(2).''.
    (b) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended--
            (1) in subsection (b)(8), by inserting ``or counterfeit in 
        vitro clinical test'' after ``counterfeit drug'';
            (2) in subsection (c)--
                    (A) by striking ``; or (5)'' and inserting ``; 
                (5)''; and
                    (B) by inserting before the period at the end the 
                following: ``; or (6) for having violated section 
                301(fff)(2) if such person acted in good faith and had 
                no reason to believe that use of the punch, die, plate, 
                stone, or other thing involved would result in an in 
                vitro clinical test being a counterfeit in vitro 
                clinical test, or for having violated section 
                301(fff)(3) if the person doing the act or causing it 
                to be done acted in good faith and had no reason to 
                believe that the in vitro clinical test was a 
                counterfeit in vitro clinical test''; and
            (3) in subsection (f)(1)--
                    (A) in subparagraph (A)--
                            (i) by inserting ``or in vitro clinical 
                        tests'' after ``which relates to devices'';
                            (ii) by inserting ``or section 587Q(a)(1)'' 
                        after ``section 704(g)''; and
                            (iii) by inserting ``or in vitro clinical 
                        tests, as applicable'' before the period at the 
                        end of the second sentence; and
                    (B) in subparagraph (B)(i), by striking ``or 
                520(f)'' and inserting ``, 520(f), 587K, or 587M,''.
    (c) Seizure.--Section 304 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 334) is amended--
            (1) in subsection (a)(2)--
                    (A) by striking ``, and (E)'' and inserting ``, 
                (E)''; and
                    (B) by inserting before the period at the end the 
                following: ``, and (F) Any in vitro clinical test that 
                is a counterfeit in vitro clinical test, (G) Any 
                container, packaging, or labeling of a counterfeit in 
                vitro clinical test, and (H) Any punch, die, plate, 
                stone, labeling, container, or other thing used or 
                designed for use in making a counterfeit in vitro 
                clinical test'';
            (2) in subsection (d)(1), by inserting ``in vitro clinical 
        test,'' after ``device,''; and
            (3) in subsection (g)--
                    (A) in paragraph (1), by inserting ``, in vitro 
                clinical test,'' after ``device'' each place it 
                appears; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by inserting ``, 
                        in vitro clinical test,'' after ``device''; and
                            (ii) in subparagraph (B), by inserting ``or 
                        in vitro clinical test'' after ``device'' each 
                        place it appears.
    (d) Debarment, Temporary Denial of Approval, and Suspension.--
Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a) is amended by adding at the end the following:
    ``(n) In Vitro Clinical Tests; Mandatory Debarment Regarding Third-
Party Inspections and Reviews.--
            ``(1) In general.--If the Secretary finds that a person has 
        been convicted of a felony for a violation of section 301(gg) 
        or 301(fff)(1), the Secretary shall debar such person from 
        being accredited under section 587Q and from carrying out 
        activities under an agreement described in section 803(b).
            ``(2) Debarment period.--The Secretary shall debar a person 
        under paragraph (1) for the following periods:
                    ``(A) The period of debarment of a person (other 
                than an individual) shall not be less than 1 year or 
                more than 10 years, but if an act leading to a 
                subsequent debarment under such paragraph occurs within 
                10 years after such person has been debarred under such 
                paragraph, the period of debarment shall be permanent.
                    ``(B) The debarment of an individual shall be 
                permanent.
            ``(3) Termination of debarment; judicial review; other 
        matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1) 
        apply with respect to a person (other than an individual) or an 
        individual who is debarred under paragraph (1) to the same 
        extent and in the same manner as such subsections apply with 
        respect to a person who is debarred under subsection (a)(1), or 
        an individual who is debarred under subsection (a)(2), 
        respectively.''.
    (e) Expanded Access to Unapproved Therapies and Diagnostics.--
Section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb) is amended--
            (1) in subsections (a) through (d)--
                    (A) by striking ``or investigational devices'' each 
                place it appears and inserting ``, investigational 
                devices, or investigational in vitro clinical tests''; 
                and
                    (B) by striking ``or investigational device'' each 
                place it appears (other than the second such place in 
                paragraph (3)(A)) of subsection (c)) and inserting ``, 
                investigational device, or investigational in vitro 
                clinical test'';
            (2) in subsection (b)(4) by striking ``or 520(g)'' each 
        place it appears and inserting ``, 520(g), or 587S'';
            (3) in subsection (c)--
                    (A) by amending the subsection heading to read: 
                ``Treatment Investigational New Drug Applications, 
                Treatment Investigational Device Exemptions, and 
                Treatment Investigational in Vitro Clinical Test 
                Exemptions.'';
                    (B) in paragraph (3)(A), by striking ``or 
                investigational device exemption in effect under 
                section 520(g)'' and inserting ``, investigational 
                device exemption in effect under section 520(g), or 
                investigational in vitro clinical test exemption under 
                section 587S'';
                    (C) by striking ``or treatment investigational 
                device exemption'' each place it appears and inserting 
                ``, treatment investigational device exemption, or 
                treatment investigational in vitro clinical test 
                exemption'';
                    (D) in paragraph (5), by striking ``or 520(g)'' and 
                inserting ``, 520(g), or 587S''; and
                    (E) in the matter following paragraph (7) by 
                striking ``or 520(g)'' each place it appears and 
                inserting ``, 520(g), or 587S''; and
            (4) by amending subsection (e) to read as follows:
    ``(e) Definitions.--In this section, the terms `investigational 
drug', `investigational device', `investigational in vitro clinical 
test', `treatment investigational new drug application', `treatment 
investigational device exemption', and `treatment investigational in 
vitro clinical test exemption' shall have the meanings given the terms 
in regulations prescribed by the Secretary.''.
    (f) Optimizing Global Clinical Trials.--Section 569A(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8a(b)) is 
amended--
            (1) by striking ``subsection'' each place it appears and 
        inserting ``paragraph''; and
            (2) by inserting ``an in vitro clinical test, as defined in 
        paragraph (ss) of such section,'' before ``or a biological 
        product''.
    (g) Patient Participation in Medical Product Discussion.--The 
heading of subsection (a) of section 569C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-8c) is amended by striking ``Drugs 
and Devices'' and inserting ``Drugs, Devices, and in Vitro Clinical 
Tests''.
    (h) Regulations and Hearings.--Clause (ii) of section 701(h)(1)(C) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) is 
amended--
            (1) by inserting ``and in vitro clinical tests'' after 
        ``devices''; and
            (2) by moving the margin of such clause 2 ems to the left.
    (i) Records.--Section 703 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 373) is amended--
            (1) by inserting ``in vitro clinical tests,'' after 
        ``devices,'' each place such term appears; and
            (2) by inserting ``in vitro clinical test,'' after 
        ``device,'' each place such term appears.
    (j) Factory Inspection.--Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374) (other than subsection (g)) is amended--
            (1) by striking ``drugs or devices'' each place it appears 
        and inserting ``drugs, devices, or in vitro clinical tests'';
            (2) in subsection (a)(1), in the fourth sentence, by 
        striking ``or chapter IX'' and inserting ``section 587S, 
        section 587M, section 587N, or chapter IX'';
            (3) after making the amendments in paragraphs (1) and (2), 
        by inserting ``in vitro clinical tests,'' after ``devices,'' 
        each place it appears;
            (4) in subsection (a)(2)(B)--
                    (A) by inserting ``or in vitro clinical tests'' 
                after ``prescribe or use devices''; and
                    (B) by inserting ``or in vitro clinical tests'' 
                after ``process devices'';
            (5) by inserting ``in vitro clinical test,'' after 
        ``device,'' each place it appears;
            (6) in subsection (e), by inserting ``, or section 587M, 
        587N, or 587S,'' after ``section 519 or 520(g)'';
            (7) in subsection (f)(3)--
                    (A) in subparagraph (A), by striking ``or'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; or''; and
                    (C) after subparagraph (B), by inserting the 
                following:
                    ``(C) is accredited under section 587Q.''; and
            (8) by adding at the end the following:
    ``(i) For purposes of this section, the term `establishment' 
includes a laboratory performing an in vitro clinical test.''.
    (k) Publicity.--Section 705(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 375(b)) is amended by inserting ``in vitro 
clinical tests,'' after ``devices,''.
    (l) Presumption.--Section 709 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379a) is amended by inserting ``in vitro 
clinical test,'' after ``device,''.
    (m) Listing and Certification of Color Additives for Foods, Drugs, 
and Cosmetics.--Section 721(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379e(a)) is amended--
            (1) in the matter preceding paragraph (1), by inserting 
        ``or in vitro clinical tests'' after ``or devices''; and
            (2) in the flush text following paragraph (2)--
                    (A) by inserting ``or an in vitro clinical test'' 
                after ``a device''; and
                    (B) by inserting ``or in vitro clinical tests'' 
                after ``devices''.
    (n) Imports and Exports.--Section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``in vitro clinical tests,'' after 
                ``devices,'' each place it appears; and
                    (B) by inserting ``in the case of an in vitro 
                clinical test, the test does not conform to the 
                applicable requirements of section 587K, or'' after 
                ``requirements of section 520(f), or'';
            (2) in subsection (d)(3)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``and no component of an in vitro 
                        clinical test or other article of in vitro 
                        clinical test that requires further 
                        processing,'' after ``health-related 
                        purposes'';
                            (ii) in clause (i), by striking ``drug or 
                        device'' and inserting ``drug, device, or in 
                        vitro clinical test''; and
                            (iii) in clause (i)(I), by inserting ``in 
                        vitro clinical test,'' after ``device,''; and
                    (B) in subparagraph (B), by inserting ``in vitro 
                clinical test,'' after ``device,'';
            (3) in subsection (e)(1), by inserting ``in vitro clinical 
        test,'' after ``device,''; and
            (4) in subsection (o)--
                    (A) by inserting ``or in vitro clinical test'' 
                after ``device''; and
                    (B) by inserting ``, or under section 587J of each 
                foreign establishment,'' after ``section 510(i) of each 
                establishment''.
    (o) Office of International Relations.--Section 803 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 383) is amended--
            (1) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``and in vitro clinical tests'' after 
                ``devices''; and
                    (B) in paragraph (1), by striking ``, and'' and 
                inserting ``and quality requirements established under 
                section 587K; and''; and
            (2) in subsection (c)--
                    (A) in paragraph (2), by inserting ``in vitro 
                clinical tests,'' after ``devices,''; and
                    (B) in paragraph (4), by inserting ``or in vitro 
                clinical tests'' after ``devices''.
    (p) Recognition of Foreign Government Inspections.--Section 
809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384e(a)(1)) is amended by inserting ``, or of foreign establishments 
registered under section 587J,'' after ``510(h)''.
    (q) Food and Drug Administration.--Section 1003(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)) is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the semicolon at the 
        end and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(F) in vitro clinical tests are analytically and 
                clinically valid;''.
    (r) Office of Women's Health.--Section 1011(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 399b(b)) is amended--
            (1) in paragraph (1), by inserting ``in vitro clinical 
        tests,'' after ``devices,''; and
            (2) in paragraph (4), by inserting ``in vitro clinical test 
        developers,'' after ``device manufacturers,''.
    (s) Countermeasure Provisions of the Public Health Service Act.--
Title III of the Public Health Service Act is amended--
            (1) in section 319F-1(a)(2)(A) (42 U.S.C. 247d-
        6a(a)(2)(A))--
                    (A) in the matter preceding clause (i)--
                            (i) by striking ``or device'' and inserting 
                        ``device''; and
                            (ii) by inserting ``or an in vitro clinical 
                        tests (as that term is defined in section 
                        201(ss) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 321(ss))),'' after ``Act (21 
                        U.S.C. 321(h))),''; and
                    (B) in each of clauses (ii) and (iii), by striking 
                ``or device'' and inserting ``device, or in vitro 
                clinical test'';
            (2) in section 319F-2(c)(1)(B) (42 U.S.C. 247d-
        6b(c)(1)(B))--
                    (A) by striking ``or device'' and inserting 
                ``device''; and
                    (B) by inserting ``, or an in vitro clinical test 
                (as that term is defined in section 201(ss) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(ss)))'' after ``Act (21 U.S.C. 321(h))),''; and
            (3) in section 319F-3(i)(7) (42 U.S.C. 247d-6d(i)(7))--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``or device'' and inserting 
                        ``device''; and
                            (ii) by inserting ``or an in vitro clinical 
                        tests (as that term is defined in section 
                        201(ss) of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 321(ss))),'' after ``Act (21 
                        U.S.C. 321(h))'';
                    (B) in subparagraph (A)--
                            (i) by moving the margin of clause (iii) 2 
                        ems to the left; and
                            (ii) in clause (iii), by striking ``or 
                        device'' and inserting ``device, or in vitro 
                        clinical test''; and
                    (C) in subparagraph (B)--
                            (i) in clause (i), by striking ``approved 
                        or cleared'' and inserting ``approved, cleared, 
                        or offered under a technology certification 
                        order''; and
                            (ii) in clause (ii), by striking ``or 
                        520(g)'' and inserting ``, 520(g), or 587S''.

SEC. 5. TRANSITION.

    (a) Implementation.--
            (1) Effective date.--
                    (A) In general.--Except as otherwise provided in 
                this section, the amendments made by this Act shall 
                take effect on October 1, 2028 (in this section and in 
                subchapter J of chapter V of the Federal Food, Drug, 
                and Cosmetic Act, as added by this Act, referred to in 
                this section as the ``effective date of this Act'').
                    (B) Exceptions.--
                            (i) In general.--The Secretary of Health 
                        and Human Services (in this section referred to 
                        as the ``Secretary'') may take the actions 
                        described in paragraph (2), and may expend such 
                        funds as the Secretary determines necessary to 
                        ensure an orderly transition prior to the 
                        effective date of this Act.
                            (ii) Implementation of certain 
                        provisions.--The Secretary may implement 
                        sections 587J and 587U of the Federal Food, 
                        Drug, and Cosmetic Act (as added by section 3) 
                        beginning on October 1, 2024, and such sections 
                        may take effect not earlier than October 1, 
                        2028, to the extent and for the purposes 
                        indicated in such sections. In the case of a 
                        developer who, between October 1, 2024, and the 
                        effective date of this Act, registers under 
                        such section 587J with respect to an article 
                        that is an in vitro clinical test, such 
                        developer shall not be required to register 
                        with respect to such article under section 510 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360).
            (2) Actions.--The Secretary--
                    (A) shall--
                            (i) within 1 year of the date of enactment 
                        of this Act, hold the public meetings described 
                        in section 587D(i) of the Federal Food, Drug, 
                        and Cosmetic Act (as added by section 3); and
                            (ii) within 3 years of the date of 
                        enactment of this Act, promulgate final 
                        regulations required under the amendments made 
                        by this Act; and
                    (B) may take additional actions after the date of 
                enactment that the Secretary determines necessary to 
                ensure an orderly transition, including--
                            (i) establishment of mitigating measures 
                        for an in vitro clinical test or category of in 
                        vitro clinical tests, which may not take effect 
                        until after the effective date described in 
                        paragraph (1)(A); and
                            (ii) establishment of the comprehensive 
                        test information system under section 587T of 
                        the Federal Food, Drug, and Cosmetic Act, as 
                        added by section 3.
            (3) Applicability of guidance and regulations.--
        Notwithstanding the date on which guidance or regulations are 
        issued under paragraph (2) and section 587K of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 3, no 
        guidance or regulations issued pursuant to the amendments made 
        by this Act shall be implemented or take effect until the 
        effective date of this Act, except as otherwise specified in 
        this Act (including the amendments made by this Act).
            (4) Implementation requirements.--In the event that the 
        Secretary fails to promulgate the regulations required under 
        section 587B(a)(4), 587D(j), or 587S(b)(1) of the Federal Food, 
        Drug, and Cosmetic Act, as added by section 3, by the deadline 
        described in subsection (a)(2)(A)(ii), the Secretary shall, 
        within 15 days of such missed deadline--
                    (A) submit a report to the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Energy and Commerce of the House of 
                Representatives providing information related to the 
                status of such regulations, including--
                            (i) a rationale for missing the applicable 
                        deadline described in such subsection;
                            (ii) a description of actions taken to the 
                        date of submission of the report to promulgate 
                        each such regulations;
                            (iii) the expected timeline for 
                        promulgating each such regulations;
                            (iv) an assessment of the impact of the 
                        delay in promulgating such regulations on 
                        developers of in vitro clinical tests, 
                        including an economic assessment; and
                            (v) an assessment of the impact of the 
                        delay in promulgating such regulations on 
                        patients; and
                    (B) open a public docket for purposes of soliciting 
                public comments on the impact of the delay in 
                promulgating such regulations.
    (b) Application of Authorities to in Vitro Clinical Tests Under 
Review on the Effective Date of This Act.--For any in vitro clinical 
test for which a submission for approval under section 515 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), clearance under 
section 510(k) of such Act (21 U.S.C. 360(k)), authorization under 
section 513(f)(2) of such Act (21 U.S.C. 360c(f)(2)), or licensure 
under section 351 of the Public Health Service Act (42 U.S.C. 262) is 
pending on the effective date of this Act, including transitional in 
vitro clinical tests as described in subsection (c), the Secretary may 
review and take action on such submission after the effective date of 
this Act according to the statutory provision under which such 
submission was submitted.
    (c) Application of Authorities to Transitional In Vitro Clinical 
Tests.--
            (1) Definition.--For purposes of this section, the term 
        ``transitional in vitro clinical test'' means an in vitro 
        clinical test that--
                    (A)(i) is first offered for clinical use during the 
                period beginning on the date that is 45 days after the 
                date of enactment of this Act and ending on the 
                effective date of this Act; or
                    (ii) is offered solely for investigational use 
                during the period beginning on the date of enactment of 
                this Act and ending on the effective date of this Act;
                    (B) is developed by a clinical laboratory certified 
                by the Secretary under section 353 of the Public Health 
                Service Act (42 U.S.C. 263a) that meets the 
                requirements for performing high-complexity testing and 
                performed--
                            (i) in the same clinical laboratory in 
                        which the test was developed and for which a 
                        certification is still in effect under such 
                        section 353 that meets the requirements to 
                        perform tests of high complexity;
                            (ii) by another laboratory for which a 
                        certificate is in effect under such section 353 
                        that meets the requirements to perform tests of 
                        high complexity, is within the same corporate 
                        organization, and has common ownership by the 
                        same parent corporation as the laboratory in 
                        which the test was developed; or
                            (iii) in the case of a test that was 
                        developed by the Centers for Disease Control 
                        and Prevention or another laboratory in a 
                        public health laboratory network coordinated or 
                        managed by the Centers for Disease Control and 
                        Prevention, by a clinical laboratory for which 
                        a certificate is in effect under such section 
                        353 that meets the requirements to perform 
                        tests of high complexity, and that is within a 
                        public health laboratory network coordinated or 
                        managed by the Centers for Disease Control and 
                        Prevention; and
                    (C) when first offered, is not approved under 
                section 515 of the Federal Food, Drug, and Cosmetic 
                Act, cleared under section 510(k) of such Act, 
                authorized under section 513(f)(2) of such Act, subject 
                to a humanitarian device exemption under section 520(m) 
                of such Act (21 U.S.C. 360j(m)), subject to an 
                exemption for investigation use under section 520(g) of 
                such Act (21 U.S.C. 360j(g)), authorized under section 
                564 of such Act (21 U.S.C. 360bbb-3), or licensed under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262).
            (2) Premarket review or technology certification.--A 
        transitional in vitro clinical test that is not exempt from 
        premarket review under section 587C of the Federal Food, Drug, 
        and Cosmetic Act, as added by section 3, may continue to be 
        offered, sold, or distributed, as applicable, without marketing 
        authorization until completion of the Secretary's review of the 
        premarket application or technology certification application 
        under section 587B or 587D, as applicable, if--
                    (A) such in vitro clinical test is a high-risk test 
                (as defined in section 587 of the Federal Food, Drug, 
                and Cosmetic Act, as added by section 3) and the 
                application for such test is submitted not later than 
                90 days after the effective date of this Act; or
                    (B) such in vitro clinical test is a moderate-risk 
                test (as defined in such section 587), the developer 
                lists the test in accordance with section 587J within 
                10 calendar days of the effective date of this 
                subchapter, and the application for such test is 
                submitted not later than 1 year after the effective 
                date of this Act.
            (3) Investigational use request.--A transitional in vitro 
        clinical test described in paragraph (1)(A)(ii) that is used in 
        a significant risk investigation may continue to be offered for 
        investigational use until completion of the Secretary's review 
        of an application under 587S, if such application is submitted 
        not later than 90 days after the effective date of this Act.
            (4) Tests approved by new york state.--Notwithstanding 
        paragraph (2), a transitional in vitro clinical test that has 
        been approved by the New York State Department of Health may 
        continue to be offered, sold, or distributed, as applicable, 
        after the effective date if--
                    (A) starting on the effective date of this Act, the 
                in vitro clinical test complies with the requirements 
                of subchapter J of the Federal Food, Drug, and Cosmetic 
                Act, as added by this Act, except for section 587B of 
                the Federal Food, Drug, and Cosmetic Act, as added by 
                section 3, and design control provisions of section 
                587K of such Act;
                    (B) each test report for the test bears a statement 
                of adequate prominence that reads as follows: ``This in 
                vitro clinical test was developed and first introduced 
                prior to the effective date of the VALID Act of 2023. 
                This test was approved by the New York State Department 
                of Health, but the test has not been reviewed by the 
                Food and Drug Administration.'';
                    (C) a premarket application under section 587B of 
                the Federal Food, Drug, and Cosmetic Act, as added by 
                section 3, or technology certification application 
                under section 587D of such Act, as added by section 3, 
                is submitted no later than--
                            (i) 5 years after the effective date of 
                        this Act, if the in vitro clinical test is 
                        approved by the New York State Department of 
                        Health as a genetic testing molecular test, a 
                        microbiology molecular test, an oncology 
                        molecular test, or any other type of molecular 
                        test; or
                            (ii) 2 years after the effective date of 
                        this Act, if the in vitro clinical test is 
                        approved by the New York State Department of 
                        Health as a type of test not described in 
                        clause (i); and
                    (D) a test in compliance with this paragraph may 
                continue to be offered, sold, or distributed, as 
                applicable, until the completion of the Secretary's 
                review of the premarket application or technology 
                certification application described in subparagraph 
                (C).
    (d) Conversion.--
            (1) Deemed premarket approval.--Beginning on the effective 
        date of this Act--
                    (A) any in vitro clinical test with a premarket 
                approval under section 515 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360e) or a licensure under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262) is deemed to be approved pursuant to an 
                application under section 587B(a) of the Federal Food, 
                Drug, and Cosmetic Act, as added by this Act; and
                    (B) any in vitro clinical test (as so defined) that 
                was cleared under section 510(k) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360(k)) or authorized 
                under section 513(f)(2) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360c(f)(2)) is deemed to be 
                approved pursuant to an application under section 
                587B(b) of the Federal Food, Drug, and Cosmetic Act, as 
                added by this Act.
            (2) Deemed investigational use exemption.--Any in vitro 
        clinical test that has an investigational device exemption in 
        effect under section 520(g) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360j(g)) is deemed to have an 
        investigational use exemption in effect under section 587S of 
        such Act, as added by this Act, beginning on the effective date 
        of this Act.
            (3) Deemed humanitarian device exemption.--Any in vitro 
        clinical test that has an approved humanitarian device 
        exemption under section 520(m) of such Act is deemed to have a 
        humanitarian test exemption under section 587A(g) of such Act, 
        as added by this Act, beginning on the effective date of this 
        Act.
            (4) Deemed designated breakthrough.--Any in vitro clinical 
        test that has received a breakthrough device designation under 
        section 515B(e)(1)(D) of such Act (21 U.S.C. 360e-3(e)(1)(D)) 
        is deemed to have a breakthrough in vitro clinical test 
        designation under section 587C of such Act, as added by this 
        Act, beginning on the effective date of this Act.
            (5) Deemed request for informal feedback.--With regard to 
        any in vitro clinical test that is the subject of a pre-
        submission request described in the guidance, ``Requests for 
        Feedback and Meetings for Medical Device Submissions: The Q-
        Submission Program'', issued by the Food and Drug 
        Administration on January 6, 2021, such request is deemed to 
        constitute a request for informal feedback under section 587F 
        of the Federal Food, Drug, and Cosmetic Act, as added by 
        section 3, beginning on the effective date of this Act.
    (e) Previously Classified Devices.--Notwithstanding section 587 of 
the Federal Food, Drug, and Cosmetic Act, as added by section 3, for 
purposes of subchapter J of chapter V of such Act, as added by section 
3, the following apply:
            (1) In the case of an in vitro clinical test type that has 
        been classified by the Secretary as a class I device pursuant 
        to section 513 of such Act (21 U.S.C. 360c), such in vitro 
        clinical test shall be low-risk, unless the in vitro clinical 
        test is a test described in the second sentence of section 
        510(l)(1) of such Act or the test is redesignated by the 
        Secretary pursuant to section 587F of such Act.
            (2) In the case of an in vitro clinical test type that has 
        been classified by the Secretary as a class II device pursuant 
        to section 513 of such Act (21 U.S.C. 360c), such in vitro 
        clinical test shall be moderate-risk, unless inaccurate results 
        from the test would be immediately life threatening or the test 
        is redesignated by the Secretary pursuant to section 587F of 
        such Act.
            (3) In the case of an in vitro clinical test type that has 
        been classified by the Secretary as a class III device pursuant 
        to section 513 of such Act (21 U.S.C. 360c) or an in vitro 
        clinical test licensed pursuant to section 351 of the Public 
        Health Service Act (42 U.S.C. 262), such in vitro clinical test 
        shall be high-risk, unless redesignated by the Secretary 
        pursuant to section 587F of the Federal Food, Drug, and 
        Cosmetic Act.

SEC. 6. EMERGENCY USE AUTHORIZATION.

    (a) In General.--Section 564 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
            (1) by inserting ``or developer'' after ``manufacturer'', 
        each place such term appears;
            (2) in subsection (a)--
                    (A) in paragraphs (1) and (4)(C), by inserting ``in 
                vitro clinical test,'' before ``or biological product'' 
                each place such term appears;
                    (B) in paragraph (2)(A), by striking ``or 515'' and 
                inserting ``515, or 587B''; and
                    (C) by adding at the end the following:
                    ``(F) The terms `develop' and `developer', with 
                respect to an in vitro clinical test, have the meanings 
                given such terms in section 587.'';
            (3) in subsection (b), by inserting ``or developer'' after 
        ``manufacturer'' each place such term appears;
            (4) in subsection (e)--
                    (A) by inserting ``or developers'' after 
                ``manufacturers'' each place such term appears;
                    (B) in paragraph (2)(B)(ii), by inserting ``or 
                develop'' after ``not manufacture'';
                    (C) in paragraph (3)--
                            (i) in subparagraph (A), by striking ``or 
                        520(f)(1)'' and inserting ``, 520(f)(1), or 
                        587V'';
                            (ii) in subparagraph (B), by striking 
                        ``and'' at the end;
                            (iii) in subparagraph (C), by striking the 
                        period and inserting `` or 587O; and''; and
                            (iv) by adding at the end the following:
                    ``(D) quality requirements (with respect to in 
                vitro clinical tests) under section 587K.''; and
                    (D) in paragraph (4)--
                            (i) in subparagraph (A), by striking ``; 
                        or'' and inserting a semicolon;
                            (ii) in subparagraph (B), by striking the 
                        period and inserting ``; or''; and
                            (iii) by adding at the end the following:
                    ``(C) with respect to in vitro clinical tests, 
                requirements applicable to restricted in vitro clinical 
                tests pursuant to section 587O.'';
            (5) in subsection (k), by striking ``or 520(g)'' and 
        inserting ``520(g), or 587S''; and
            (6) in subsection (m)--
                    (A) in the subsection heading, by striking 
                ``Laboratory Tests Associated With Devices'' inserting 
                ``in Vitro Clinical Tests'' after ``Devices''; and
                    (B) in paragraph (1)--
                            (i) by striking ``to a device'' and 
                        inserting ``to an in vitro clinical test''; and
                            (ii) by striking ``such device'' and 
                        inserting ``such in vitro clinical test''.
    (b) Emergency Use of Medical Products.--Section 564A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2), by inserting ``in vitro 
                clinical test,'' after ``device,''; and
                    (B) by adding at the end the following:
            ``(3) Developer.--The term `developer', with respect to an 
        in vitro clinical test, has the meaning given such term in 
        section 587.'';
            (2) by inserting ``or developer'' after ``manufacturer'' 
        each place it appears; and
            (3) in subsection (c)(1)--
                    (A) by inserting ``or quality requirements'' after 
                ``good manufacturing practice requirements''; and
                    (B) by striking ``or 520(f)(1)'' and inserting ``, 
                520(f)(1), or 587K''.
    (c) Products Held for Emergency Use.--Section 564B(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b(2)) is 
amended--
            (1) in subparagraph (A), by striking ``or 515'' and 
        inserting ``515, or 587B''; and
            (2) in subparagraph (B), by striking ``or 520'' and 
        inserting 520, or 587S.

SEC. 7. ANTIMICROBIAL SUSCEPTIBILITY TESTS.

    Section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a-2) is amended--
            (1) in subsection (a)(1)(C)--
                    (A) by striking ``clear under section 510(k), 
                classify under section 513(f)(2), or approve under 
                section 515'' and inserting ``approve under section 
                587B, exempt from premarket review under section 587C, 
                or grant a technology certification order under section 
                587D''; and
                    (B) by striking ``testing devices'' and inserting 
                ``in vitro clinical tests'';
            (2) in subsection (c)(5)--
                    (A) by striking ``drug or device'' and inserting 
                ``drug, device, or in vitro clinical test''; and
                    (B) by striking ``the drug or the device'' and 
                inserting ``the drug, device, or in vitro clinical 
                test'';
            (3) in subsection (e)--
                    (A) in the heading, by striking ``Testing Devices'' 
                and inserting ``In Vitro Clinical Tests'';
                    (B) in paragraph (1)--
                            (i) by striking ``510, 513, and 515,'' and 
                        inserting ``587B, and 587D'';
                            (ii) by striking ``antimicrobial 
                        susceptibility testing device'' and inserting 
                        ``antimicrobial susceptibility in vitro 
                        clinical test''; and
                            (iii) by striking ``such device'' and 
                        inserting ``such in vitro clinical test''; and
                    (C) in paragraph (2)--
                            (i) in the heading, by striking ``testing 
                        devices'' and inserting ``in vitro clinical 
                        tests'';
                            (ii) in subparagraphs (A) and (B) (other 
                        than clause (iii) of such subparagraph (B)), by 
                        striking ``device'' each place it appears and 
                        inserting ``in vitro clinical test'';
                            (iii) in subparagraph (B)(iii), by striking 
                        ``a device'' and inserting ``an in vitro 
                        clinical test''; and
                            (iv) by amending subparagraph (C) to read 
                        as follows:
                    ``(C) The antimicrobial susceptibility in vitro 
                clinical test meets all other requirements to be 
                approved under section 587B, to be exempted from 
                premarket review under section 587C, or to be offered 
                under a technology certification order under section 
                587D.'';
            (4) in subsection (f), by amending paragraph (1) to read as 
        follows:
            ``(1) The term `antimicrobial susceptibility in vitro 
        clinical test' means an in vitro clinical test that utilizes 
        susceptibility test interpretive criteria to determine and 
        report the in vitro susceptibility of certain microorganisms to 
        a drug (or drugs).''; and
            (5) in subsection (g)(2)--
                    (A) by amending the matter preceding subparagraph 
                (A) to read as follows:
            ``(2) with respect to approving an application under 
        section 587B or granting a technology certification order under 
        section 587D--''; and
                    (B) in subparagraph (A)--
                            (i) by striking ``device'' and inserting 
                        ``in vitro clinical test''; and
                            (ii) by striking ``antimicrobial 
                        susceptibility testing device'' and inserting 
                        ``antimicrobial susceptibility in vitro 
                        clinical test''.

SEC. 8. COMBINATION PRODUCTS.

    (a) In General.--Section 503(g) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``or 
                biological product'' and inserting ``in vitro clinical 
                test (except for a product constituted of a device and 
                an in vitro clinical test), or biological product'';
                    (B) in subparagraph (B), by adding at the end the 
                following: ``For purposes of this Act, a product that 
                constitutes a combination of a device and an in vitro 
                clinical test is not a combination product within the 
                meaning of this subsection and an in vitro clinical 
                test that is offered as a separate product intended to 
                inform the use of a drug, biological product, or device 
                is not a combination product within the meaning of this 
                subsection.''; and
                    (C) in subparagraph (D)(ii)--
                            (i) by inserting ``or in vitro clinical 
                        test'' after ``device''; and
                            (ii) by inserting ``and in vitro clinical 
                        tests'' before ``shall'';
            (2) in paragraph (3), by striking ``safety and 
        effectiveness or substantial equivalence'' and inserting 
        ``safety and effectiveness, substantial equivalence, or 
        analytical validity and clinical validity'' before ``for the 
        approved constituent part'';
            (3) in paragraph (4)--
                    (A) in subparagraph (A), by striking ``or 513(f)(2) 
                (submitted in accordance with paragraph (5))'' and 
                inserting ``513(f)(2) (submitted in accordance with 
                paragraph (5)), 587B, or 587D''; and
                    (B) in subparagraph (C), by striking ``or 515'' and 
                inserting ``515, or 587B, or that is under an order 
                under section 587D'';
            (4) in paragraph (5)(A), by striking ``or 510(k)'' and 
        inserting ``, 510(k), 587B, or 587D'';
            (5) in paragraph (7), by striking ``or substantial 
        equivalence'' and inserting ``, substantial equivalence, or 
        analytical validity and clinical validity'';
            (6) in paragraph (8), by adding at the end the following:
                    ``(I) This paragraph shall not apply to a product 
                constituted of a device and an in vitro clinical 
                test.''; and
            (7) in paragraph (9)--
                    (A) in subparagraph (C)(i), by striking ``or 
                520(g)'' and inserting ``520(g), 587B, or 587D''; and
                    (B) in subparagraph (D), by striking ``or 520'' and 
                inserting ``520, 587B, or 587D''.
    (b) Classification of Products.--Section 563 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) is amended by adding at the 
end the following:
    ``(d) Exemption.--This section shall not apply to a product 
constituted of only a device and an in vitro clinical test.''.

SEC. 9. RESOURCES.

    (a) Findings.--Congress finds that the fees authorized by this 
section will be dedicated to meeting the goals identified in the 
letters from the Secretary of Health and Human Services to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, 
as set forth in the Congressional Record.
    (b) Establishment of User Fee Program.--
            (1) Development of user fees for in vitro clinical tests.--
                    (A) In general.--Beginning not later than October 
                1, 2025, the Secretary of Health and Human Services (in 
                this section referred to as the ``Secretary'') shall 
                initiate the development of recommendations in 
                accordance with this section to present to Congress 
                with respect to the goals, and plans for meeting the 
                goals, for the process for the review of in vitro 
                clinical test submissions and applications under 
                subchapter J of chapter V of the Federal Food, Drug, 
                and Cosmetic Act, as added by this Act, for the first 4 
                fiscal years after fiscal year 2028 and for the 
                authorization of the In Vitro Clinical Test User Fee 
                Program for such fiscal years. In developing such 
                recommendations, the Secretary shall consult with--
                            (i) the Committee on Health, Education, 
                        Labor, and Pensions of the Senate;
                            (ii) the Committee on Energy and Commerce 
                        of the House of Representatives;
                            (iii) scientific and academic experts;
                            (iv) health care professionals;
                            (v) representatives of patient and consumer 
                        advocacy groups; and
                            (vi) the regulated industry.
                    (B) Prior public input.--Prior to beginning 
                negotiations with the regulated industry on the 
                authorization of the In Vitro Clinical Test User Fee 
                Program, as described in this section, the Secretary 
                shall--
                            (i) publish a notice in the Federal 
                        Register requesting public input on the 
                        authorization of user fees;
                            (ii) hold a public meeting at which the 
                        public may present its views on the 
                        authorization, including specific suggestions 
                        for the recommendations submitted under 
                        subparagraph (E);
                            (iii) provide a period of 30 days after the 
                        public meeting to obtain written comments from 
                        the public suggesting changes to the In Vitro 
                        Clinical Test User Fee Program; and
                            (iv) publish any comments received under 
                        clause (iii) on the website of the Food and 
                        Drug Administration.
                    (C) Periodic consultation.--Not less frequently 
                than once every month during negotiations with the 
                regulated industry, the Secretary shall hold 
                discussions with representatives of patient and 
                consumer advocacy groups to continue discussions of the 
                authorization of the In Vitro Clinical Test User Fee 
                Program and to solicit suggestions to be included in 
                the recommendations transmitted to Congress under 
                subparagraph (F).
                    (D) Updates to congress.--The Secretary, in 
                consultation with regulated industry, shall provide 
                regular updates on negotiations on the reauthorization 
                of the In Vitro Clinical Test User Fee Program to the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives.
                    (E) Public review of recommendations.--After 
                negotiations with the regulated industry, the Secretary 
                shall--
                            (i) present the recommendations developed 
                        under subparagraph (A) to the Committee on 
                        Health, Education, Labor, and Pensions of the 
                        Senate and the Committee on Energy and Commerce 
                        of the House of Representatives;
                            (ii) publish such recommendations in the 
                        Federal Register;
                            (iii) provide for a period of 30 days for 
                        the public to provide written comments on such 
                        recommendations;
                            (iv) hold a meeting at which the public may 
                        present its views on such recommendations; and
                            (v) after consideration of such public 
                        views and comments, revise such recommendations 
                        as necessary.
                    (F) Transmittal of recommendations.--
                            (i) In general.--Not later than January 15, 
                        2027, the Secretary shall transmit to Congress 
                        the revised recommendations under subparagraph 
                        (A), a summary of the views and comments 
                        received under such subparagraph, and any 
                        changes made to the recommendations in response 
                        to such views and comments.
                            (ii) Recommendation requirements.--The 
                        recommendations transmitted under this 
                        subparagraph shall--
                                    (I) include the number of full-time 
                                equivalent employees per fiscal year 
                                that are agreed to be hired to carry 
                                out the goals included in such 
                                recommendations for each year of the 5-
                                year period;
                                    (II) provide that the amount of 
                                operating reserve balance in the user 
                                fee program established under this 
                                section is not more than the equivalent 
                                of 10 weeks of operating reserve;
                                    (III) require the development of a 
                                strategic plan for any surplus within 
                                the operating reserve account above the 
                                10-week operating reserve within 2 
                                years of the establishment of the 
                                program;
                                    (IV) include an operating reserve 
                                adjustment such that, if the Secretary 
                                has an operating reserve balance in 
                                excess of 10 weeks of such operating 
                                reserves, the Secretary shall decrease 
                                such fee revenue and fees to provide 
                                for not more than 10 weeks of such 
                                operating reserves;
                                    (V) if an adjustment is made as 
                                described in subclause (IV), provide 
                                the rationale for the amount of the 
                                decrease in fee revenue and fees shall 
                                be contained in the Federal Register; 
                                and
                                    (VI) provide that the fees assessed 
                                and collected for the full-time 
                                equivalent employees at the Center for 
                                Devices and Radiological Health, with 
                                respect to which the majority of time 
                                reporting data indicates are dedicated 
                                to the process for the review of in 
                                vitro clinical test submissions and 
                                applications under paragraph (5), are 
                                not supported by the funds authorized 
                                to be collected and assessed under 
                                section 738 of the Federal Food, Drug, 
                                and Cosmetic Act (21 U.S.C. 379j).
                    (G) Publication of recommendations.--The Secretary 
                shall publish on the website of the Food and Drug 
                Administration the revised recommendations under 
                subparagraph (F), a summary of the recommendations, 
                views, and comments received under subparagraphs (B), 
                (C), and (E), and any changes made to the 
                recommendations originally proposed by the Secretary in 
                response to such recommendations, views, and comments.
                    (H) Minutes of negotiation meetings.--
                            (i) Public availability.--The Secretary 
                        shall make publicly available, on the website 
                        of the Food and Drug Administration, minutes of 
                        all negotiation meetings conducted under this 
                        subsection between the Food and Drug 
                        Administration and the regulated industry not 
                        later than 30 days after such meeting.
                            (ii) Content.--The minutes described under 
                        clause (i) shall summarize any substantive 
                        proposal made by any party to the negotiations, 
                        any significant controversies or differences of 
                        opinion during the negotiations, and the 
                        resolution of any such controversy or 
                        difference of opinion.
            (2) Establishment of user fee program.--Effective on 
        October 1, 2028, provided that the Secretary transmits the 
        recommendations under paragraph (1)(F), the Secretary is 
        authorized to collect user fees relating to the review of in 
        vitro clinical test submissions and applications submitted 
        under subchapter J of chapter V of the Federal Food, Drug, and 
        Cosmetic Act, as added by this Act, and any other activities or 
        goals included in recommendations transmitted to Congress 
        pursuant to this subsection. Fees under such program shall be 
        assessed and collected only if the requirements under paragraph 
        (4) are met.
            (3) Audit.--
                    (A) In general.--Beginning 2 years after first 
                receiving a user fee applicable to submission of an in 
                vitro clinical test application submitted under 
                subchapter J of chapter V of the Federal Food, Drug, 
                and Cosmetic Act, as added by this Act, the Secretary 
                shall, on a biennial basis, perform an audit of the 
                costs of reviewing such applications and any other 
                activities under such subchapter J included in 
                recommendations transmitted to Congress pursuant to 
                this subsection. Such an audit shall compare the costs 
                of reviewing such applications and other activities 
                under such subchapter J to the amount of the user fee 
                applicable to such applications and make any necessary 
                adjustments as described in subparagraph (B).
                    (B) Alteration of user fee.--The following 
                adjustments shall apply with respect to audits 
                performed under subparagraph (A):
                            (i) If the audit performed 2 years after 
                        first receiving a user fee applicable to 
                        submission of an in vitro clinical test 
                        application described under subparagraph (A) 
                        indicates that the user fees collected for 
                        purposes of such subchapter J exceed 33 percent 
                        of the costs of reviewing such applications and 
                        carrying out activities included in 
                        recommendations transmitted to Congress 
                        pursuant to this subsection, the Secretary 
                        shall alter the user fees applicable to 
                        applications submitted under such subchapter J 
                        such that the user fees do not exceed such 
                        percentage.
                            (ii) If the audit performed 6 years after 
                        first receiving a user fee applicable to 
                        submission of an in vitro clinical test 
                        application described under subparagraph (A) 
                        indicates that the user fees collected for 
                        purposes of such subchapter J exceed 40 percent 
                        of the costs of reviewing such applications, 
                        and carrying out activities included in 
                        recommendations transmitted to Congress 
                        pursuant to this subsection, the Secretary 
                        shall alter the user fees applicable to 
                        applications submitted under such subchapter J 
                        such that the user fees do not exceed such 
                        percentage.
                            (iii) If the audit performed 12 years after 
                        first receiving a user fee applicable to 
                        submission of an in vitro clinical test 
                        application described under subparagraph (A), 
                        and any audit performed after such date, 
                        indicates that the user fees collected for 
                        purposes of such subchapter J exceed 49 percent 
                        of the costs of reviewing such applications, 
                        and carrying out activities included in 
                        recommendations transmitted to Congress 
                        pursuant to this subsection, the Secretary 
                        shall alter the user fees applicable to 
                        applications submitted under such subchapter J 
                        such that the user fees do not exceed such 
                        percentage.
                    (C) Accounting standards.--The Secretary shall 
                perform an audit under subparagraph (A) in conformance 
                with the accounting principles, standards, and 
                requirements prescribed by the Comptroller General of 
                the United States under section 3511 of title 31, 
                United States Code, to ensure the validity of any 
                potential variability.
                    (D) Implementation requirements.--In the event that 
                the Secretary fails to promulgate the regulations 
                described in section 587B(a)(4), 587D(j), or 587S(b)(1) 
                of the Federal Food, Drug, and Cosmetic Act, as added 
                by section 3, by the applicable deadline for each such 
                regulations as described in section 5(a)(2)(A)(ii), the 
                Secretary shall provide that the user fees applicable 
                to applications submitted under subchapter J of chapter 
                V of the Federal Food, Drug, and Cosmetic Act, as added 
                by section 3, do not exceed 30 percent of the costs of 
                reviewing such applications.
            (4) Conditions.--The user fee program described in this 
        subsection shall take effect only if the Food and Drug 
        Administration issues a regulation related to the review 
        requirements for in vitro diagnostic tests that would be 
        subject to premarket review under section 587B of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 3, the review 
        requirements for test categories eligible for technology 
        certification under section 587D of such Act, as added by 
        section 3, and the parameters for the test categories that 
        would be exempt from any review under subchapter J of chapter V 
        of such Act.
            (5) User fee program definitions and resource 
        requirements.--
                    (A) In general.--The term ``process for the review 
                of in vitro clinical test submissions and 
                applications'' means the following activities of the 
                Secretary with respect to the review of in vitro 
                clinical test premarket and technology certification 
                applications including supplements for such 
                applications:
                            (i) The activities necessary for the review 
                        of premarket applications, premarket reports, 
                        technology certification applications, and 
                        supplements to such applications.
                            (ii) Actions related to submissions in 
                        connection with in vitro clinical test 
                        development, the issuance of action letters 
                        that allow the marketing of in vitro clinical 
                        tests or which set forth in detail the specific 
                        deficiencies in such applications, reports, 
                        supplements, or submissions and, where 
                        appropriate, the actions necessary to support 
                        the development of in vitro clinical tests.
                            (iii) The inspection of manufacturing 
                        establishments and other facilities undertaken 
                        as part of the Secretary's review of pending 
                        premarket applications, technology 
                        certifications, and supplements.
                            (iv) Monitoring of research conducted in 
                        connection with the review of such 
                        applications, supplements, and submissions.
                            (v) Review of in vitro clinical test 
                        applications subject to section 351 of the 
                        Public Health Service Act (42 U.S.C. 262) and 
                        activities conducted in anticipation of the 
                        submission of such applications for 
                        investigational use under section 587S of the 
                        Federal Food, Drug, and Cosmetic Act (as added 
                        by section 3).
                            (vi) The development of guidance, policy 
                        documents, or regulations to improve the 
                        process for the review of premarket 
                        applications, technology certification 
                        applications, and supplements.
                            (vii) The development of voluntary test 
                        methods, consensus standards, or mandatory 
                        performance standards in connection with the 
                        review of such applications, supplements, or 
                        submissions and related activities.
                            (viii) The provision of technical 
                        assistance to in vitro clinical test developers 
                        in connection with the submission of such 
                        applications, reports, supplements, or 
                        submissions.
                            (ix) Any activity undertaken in connection 
                        with the initial classification or 
                        reclassification of an in vitro clinical test 
                        in connection with any requirement for approval 
                        or eligibility for an exemption from premarket 
                        review of an in vitro clinical test.
                            (x) Any activity undertaken in connection 
                        with making a pathway determination of an in 
                        vitro clinical test, including the 
                        identification, establishment, and 
                        implementation of mitigation measures.
                            (xi) Evaluation of postmarket studies 
                        required as a condition of an approval of a 
                        premarket application of an in vitro clinical 
                        test and ensuring such studies are conducted as 
                        required.
                            (xii) Any activity undertaken in connection 
                        with ensuring in vitro clinical tests offered 
                        under an exemption from premarket review 
                        pursuant to section 587C or 587G meet the 
                        criteria for such exemption and the applicable 
                        standard.
                            (xiii) Compiling, developing, and reviewing 
                        information on in vitro clinical tests 
                        necessary to identify issues with the ability 
                        of in vitro clinical tests to meet the 
                        applicable standard, as applicable.
                    (B) Resource requirements.--Fees collected and 
                assessed under this section shall be used for the 
                process for the review of in vitro clinical test 
                applications, as described in subparagraph (A), and 
                shall--
                            (i) be subject to the limitation under 
                        section 738(g)(3) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 379j(g)(3)), in the 
                        same manner that fees collected and assessed 
                        under section 737(9)(C) of such Act (21 U.S.C. 
                        379i(9)(C)) are subject to such limitation;
                            (ii) include travel expenses for officers 
                        and employees of the Food and Drug 
                        Administration only if the Secretary determines 
                        that such travel is directly related to an 
                        activity described in subparagraph (A); and
                            (iii) not be allocated to purposes 
                        described under section 722(a) of the 
                        Consolidated Appropriations Act, 2018 (Public 
                        Law 115-141).
    (c) Reports.--
            (1) Performance report.--
                    (A) In general.--
                            (i) General requirements.--Beginning with 
                        fiscal year 2028, for each fiscal year for 
                        which fees are collected under this section, 
                        the Secretary shall prepare and submit to the 
                        Committee on Health, Education, Labor, and 
                        Pensions of the Senate and the Committee on 
                        Energy and Commerce of the House of 
                        Representatives annual reports concerning the 
                        progress of the Food and Drug Administration in 
                        achieving the goals identified in the 
                        recommendations transmitted to Congress by the 
                        Secretary pursuant to subsection (b)(1)(F) 
                        during such fiscal year and the future plans of 
                        the Food and Drug Administration for meeting 
                        the goals.
                            (ii) Additional information.--Beginning 
                        with fiscal year 2028, the annual report under 
                        this subparagraph shall include the progress of 
                        the Food and Drug Administration in achieving 
                        the goals, and future plans for meeting the 
                        goals, including--
                                    (I) the number of premarket 
                                applications filed under section 587B 
                                of the Federal Food, Drug, and Cosmetic 
                                Act during the applicable fiscal year;
                                    (II) the number of technology 
                                certification applications submitted 
                                under section 587D of the Federal Food, 
                                Drug, and Cosmetic Act during the 
                                applicable fiscal year for each review 
                                division;
                                    (III) the number of breakthrough 
                                designations under section 587I of the 
                                Federal Food, Drug, and Cosmetic Act 
                                during the applicable fiscal year; and
                                    (IV) the number of information 
                                requests requested by the Secretary 
                                pursuant to section 587G(d) of such 
                                Act.
                            (iii) Real-time reporting.--
                                    (I) In general.--Not later than 30 
                                calendar days after the end of the 
                                second quarter of fiscal year 2028, and 
                                not later than 30 calendar days after 
                                the end of each quarter of each fiscal 
                                year thereafter, the Secretary shall 
                                post the data described in subclause 
                                (II) on the website of the Food and 
                                Drug Administration for such quarter 
                                and on a cumulative basis for such 
                                fiscal year, and may remove duplicative 
                                data from the annual report under this 
                                subparagraph.
                                    (II) Data.--The Secretary shall 
                                post the following data in accordance 
                                with subclause (I):
                                            (aa) The number and titles 
                                        of draft and final regulations 
                                        on topics related to the 
                                        process for the review of in 
                                        vitro clinical test submissions 
                                        and applications, and whether 
                                        such regulations were required 
                                        by statute or pursuant to the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(F).
                                            (bb) The number and titles 
                                        of draft and final guidance on 
                                        topics related to the process 
                                        for the review of in vitro 
                                        clinical test submissions and 
                                        applications, and whether such 
                                        guidances were issued as 
                                        required by statute or pursuant 
                                        to the recommendations 
                                        transmitted to Congress by the 
                                        Secretary pursuant to 
                                        subsection (b)(1)(F).
                                            (cc) The number and titles 
                                        of public meetings held on 
                                        topics related to the process 
                                        for the review of in vitro 
                                        clinical tests, and if such 
                                        meetings were required by 
                                        statute or pursuant to the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(F).
                            (iv) Rationale for ivct user fee program 
                        changes.--Beginning with fiscal year 2028, the 
                        Secretary shall include in the annual 
                        performance report under paragraph (1)--
                                    (I) data, analysis, and discussion 
                                of the changes in the number of 
                                individuals hired as agreed upon in the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(F) and the number of remaining 
                                vacancies, the number of full-time 
                                equivalents funded by fees collected 
                                pursuant to this section, and the 
                                number of full-time equivalents funded 
                                by budget authority at the Food and 
                                Drug Administration by each division 
                                within the Center for Devices and 
                                Radiological Health, the Center for 
                                Biologics Evaluation and Research, the 
                                Office of Regulatory Affairs, and the 
                                Office of the Commissioner;
                                    (II) data, analysis, and discussion 
                                of the changes in the fee revenue 
                                amounts and costs for the process for 
                                the review of in vitro clinical test 
                                submissions and applications, including 
                                identifying--
                                            (aa) drivers of such 
                                        changes; and
                                            (bb) changes in the average 
                                        total cost per full-time 
                                        equivalent in the in vitro 
                                        clinical test review program;
                                    (III) for each of the Center for 
                                Devices and Radiological Health, the 
                                Center for Biologics Evaluation and 
                                Research, the Office of Regulatory 
                                Affairs, and the Office of the 
                                Commissioner, the number of employees 
                                for whom time reporting is required and 
                                the number of employees for whom time 
                                reporting is not required; and
                                    (IV) data, analysis, and discussion 
                                of the changes in the average full-time 
                                equivalent hours required to complete 
                                review of each type of in vitro 
                                clinical test application.
                            (v) Analysis.--For each fiscal year, the 
                        Secretary shall include in the report under 
                        clause (i) an analysis of the following:
                                    (I) The difference between the 
                                aggregate number of premarket 
                                applications filed under section 587B 
                                or section 587D of the Federal Food, 
                                Drug, and Cosmetic Act and the 
                                aggregate number of major deficiency 
                                letters, not approvable letters, and 
                                denials for such applications issued by 
                                the agency, accounting for--
                                            (aa) the number of 
                                        applications filed under each 
                                        of sections 587B and 587D of 
                                        the Federal Food, Drug, and 
                                        Cosmetic Act during one fiscal 
                                        year for which a decision is 
                                        not scheduled to be made until 
                                        the following fiscal year; and
                                            (bb) the aggregate number 
                                        of applications under each of 
                                        sections 587B and 587D of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act for each fiscal 
                                        year that did not meet the 
                                        goals as identified by the 
                                        recommendations transmitted to 
                                        Congress by the Secretary 
                                        pursuant to subsection 
                                        (b)(1)(F).
                                    (II) Relevant data to determine 
                                whether the Center for Devices and 
                                Radiological Health has met performance 
                                enhancement goals identified by the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(F).
                                    (III) The most common causes and 
                                trends for external or other 
                                circumstances affecting the ability of 
                                the Food and Drug Administration to 
                                meet review time and performance 
                                enhancement goals identified by the 
                                recommendations transmitted to Congress 
                                by the Secretary pursuant to subsection 
                                (b)(1)(F).
                    (B) Publication.--With regard to information to be 
                reported by the Food and Drug Administration to 
                industry on a quarterly and annual basis pursuant to 
                recommendations transmitted to Congress by the 
                Secretary pursuant to subsection (b)(1)(F), the 
                Secretary shall make such information publicly 
                available on the website of the Food and Drug 
                Administration not later than 60 days after the end of 
                each quarter or 120 days after the end of each fiscal 
                year, respectively, to which such information applies.
                    (C) Updates.--The Secretary shall include in each 
                report under subparagraph (A) information on all 
                previous cohorts for which the Secretary has not given 
                a complete response on all in vitro clinical test 
                premarket applications and technology certification 
                orders and supplements, premarket, and technology 
                certification notifications in the cohort.
            (2) Corrective action report.--Beginning with fiscal year 
        2029, for each fiscal year for which fees are collected under 
        this section, the Secretary shall prepare and submit a 
        corrective action report to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives. 
        The report shall include the following information, as 
        applicable:
                    (A) Goals met.--For each fiscal year, if the 
                Secretary determines, based on the analysis under 
                paragraph (1)(A)(v), that each of the goals identified 
                by the recommendations transmitted to Congress by the 
                Secretary pursuant to subsection (b)(1)(F) for the 
                applicable fiscal year have been met, the corrective 
                action report shall include recommendations on ways in 
                which the Secretary can improve and streamline the in 
                vitro clinical test premarket application and 
                technology certification review process.
                    (B) Goals missed.--For each of the goals identified 
                by the letters described in recommendations transmitted 
                to Congress by the Secretary pursuant to subsection 
                (b)(1)(F) for the applicable fiscal year that the 
                Secretary determines to not have been met, the 
                corrective action report shall include--
                            (i) a justification for such determination;
                            (ii) a description of the types of 
                        circumstances, in the aggregate, under which 
                        applications or reports submitted under 
                        sections 587B and 587D of the Federal Food, 
                        Drug, and Cosmetic Act missed the review goal 
                        times but were approved during the first cycle 
                        review, as applicable;
                            (iii) a summary and any trends with regard 
                        to the circumstances for which a review goal 
                        was missed; and
                            (iv) the performance enhancement goals that 
                        were not achieved during the previous fiscal 
                        year and a description of efforts the Food and 
                        Drug Administration has put in place for the 
                        fiscal year in which the report is submitted to 
                        improve the ability of such agency to meet each 
                        such goal for the such fiscal year.
            (3) Fiscal report.--
                    (A) In general.--For fiscal years 2029 and annually 
                thereafter, not later than 120 days after the end of 
                each fiscal year during which fees are collected under 
                this section, the Secretary shall prepare and submit to 
                the Committee on Health, Education, Labor, and Pensions 
                of the Senate and the Committee on Energy and Commerce 
                of the House of Representatives, a report on the 
                implementation of the authority for such fees during 
                such fiscal year and the use, by the Food and Drug 
                Administration, of the fees collected during such 
                fiscal year for which the report is made.
                    (B) Contents.--Such report shall include 
                expenditures delineated by budget authority and user 
                fee dollars related to administrative expenses and 
                information technology infrastructure contracts and 
                expenditures.
                    (C) Operating reserve.--Such report shall provide 
                the amount of operating reserves of carryover user fees 
                available each year, and any planned allocations or 
                obligations of such balance of operating reserves for 
                the program.
            (4) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) through (3) available to 
        the public on the website of the Food and Drug Administration.
            (5) Enhanced communication.--
                    (A) Communications with congress.--Each fiscal 
                year, as applicable and requested, representatives from 
                the Centers with expertise in the review of in vitro 
                clinical tests shall meet with representatives from the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives to report on the contents 
                described in the reports under this section.
                    (B) Participation in congressional hearing.--Each 
                fiscal year, as applicable and requested, 
                representatives from the Food and Drug Administration 
                shall participate in a public hearing before the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives, to report on the contents 
                described in the reports under this section. Such 
                hearing shall occur not later than 120 days after the 
                end of each fiscal year for which fees are collected 
                under this section.

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    For purposes of funding implementation of this Act (including the 
amendments made by this Act), including undertaking activities for the 
development of regulations and guidances, hiring of necessary staff, 
and the development of technology systems to implement this Act 
(including the amendments made by this Act) in a timely, effective, and 
efficient manner, there is authorized to be appropriated $480,000,000, 
to remain available through the end of fiscal year 2028.

SEC. 11. GUIDANCE ON DIAGNOSTIC INNOVATION.

    Not later than January 1, 2025, the Secretary shall issue guidance 
to assist developers of in vitro clinical tests intended to identify or 
diagnose rare diseases and in vitro clinical tests intended to address 
an unmet medical need. Such guidance shall include considerations for 
addressing barriers to developing sufficient data to demonstrate 
clinical validity for such tests, such as challenges associated with 
data collection and obstacles to the timely generation of evidence.

SEC. 12. GAO REPORT ON UNIQUE CONSIDERATIONS.

    Not later than 3 years after the date of enactment of this Act, the 
Comptroller General of the United States shall submit to the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representatives a 
report--
            (1) evaluating the unique considerations for hospital-based 
        laboratories, laboratories serving academic medical centers, 
        and other health care practitioners, as appropriate, in 
        implementing this Act, including the amendments made by this 
        Act; and
            (2) including recommendations based on the findings of the 
        report.

SEC. 13. ASSESSMENTS.

    Section 1834A(g) of the Social Security Act (42 U.S.C. 1395m-1(g)) 
is amended by adding at the end the following new paragraph:
            ``(3) Determinations with respect to in vitro clinical 
        tests.--On or after the date that is 45 days after the date of 
        enactment of the VALID Act of 2023, for purposes of determining 
        whether an in vitro clinical test (as defined in section 
        201(ss) of the Federal Food, Drug, and Cosmetic Act) is 
        reasonable and necessary for the diagnosis or treatment of 
        illness or injury (under section 1862(a)(1)(A)), any assessment 
        of the analytical validity or clinical validity of such test 
        shall apply the definitions given such terms in subchapter J of 
        chapter V of the Federal Food, Drug, and Cosmetic Act.''.

SEC. 14. SEVERABILITY.

    If any provision of this Act is declared unconstitutional, or the 
applicability of this Act to any person or circumstance is held 
invalid, the constitutionality of the remainder of this Act and the 
applicability thereof to other persons and circumstances shall not be 
affected.
                                 <all>