[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2422 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2422

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                 third-party quality system assessment.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

 Mr. Shimkus introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
                 third-party quality system assessment.

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

SECTION 1. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.

    (a) Establishment of Third-Party Quality System Assessment 
Program.--Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 524A (21 U.S.C. 360n-1) the 
following new section:

``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.

    ``(a) Accreditation and Assessment.--
            ``(1) In general; certification of device quality system.--
        The Secretary shall, in accordance with this section, establish 
        a third-party quality system assessment program--
                    ``(A) to accredit persons to assess whether a 
                requestor's quality system, including its design 
                controls, can reasonably assure the safety and 
                effectiveness of in-scope devices subject to device-
                related changes (as defined in paragraph (2));
                    ``(B) under which accredited persons shall, as 
                applicable, certify that a requestor's quality system 
                meets the criteria issued under paragraph (5) with 
                respect to the in-scope devices at issue; and
                    ``(C) under which the Secretary shall rely on such 
                certifications for purposes of determining the safety 
                and effectiveness of in-scope devices subject to the 
                device-related changes involved, in lieu of compliance 
                with the following submission requirements:
                            ``(i) A thirty-day notice (as defined in 
                        paragraph (2)).
                            ``(ii) A Special PMA supplement (as defined 
                        in paragraph (2)).
            ``(2) Definitions.--For purposes of this sectionU
                    ``(A) the term `device-related changes' means 
                changes made by a requestor with respect to in-scope 
                devices, which are--
                            ``(i) manufacturing changes subject to a 
                        30-day notice;
                            ``(ii) changes that qualify for a Special 
                        PMA supplement; and
                            ``(iii) such other changes relating to the 
                        devices or the device manufacturing process as 
                        the Secretary determines appropriate;
                    ``(B) the term `in-scope device' means a device 
                within the scope of devices agreed to by the requestor 
                and the accredited person for purposes of a request for 
                certification under this section;
                    ``(C) the term `quality system' means a quality 
                system described in section 520(f);
                    ``(D) the term `requestor' means a device 
                manufacturer that is seeking certification under this 
                section of a quality system used by such manufacturer;
                    ``(E) the term `Special PMA' means a Special PMA 
                supplement under section 814.39(d) of title 21, Code of 
                Federal Regulations (or any successor regulations); and
                    ``(F) the term `thirty-day notice' means a notice 
                described in section 515(d)(6).
            ``(3) Accreditation process; accreditation renewal.--Except 
        as inconsistent with this section, the process and 
        qualifications for accreditation of persons and renewal of such 
        accreditation under section 704(g) shall apply with respect to 
        accreditation of persons and renewal of such accreditation 
        under this section.
            ``(4) Use of accredited parties to conduct assessments.--
                    ``(A) Initiation of assessment services.--
                            ``(i) Date assessments authorized.--
                        Beginning after issuance of the final guidance 
                        under paragraph (5), an accredited person may 
                        conduct an assessment under this section.
                            ``(ii) Initiation of assessments.--Use of 
                        one or more accredited persons to assess a 
                        requestor's quality system under this section 
                        with respect to in-scope devices shall be at 
                        the initiation of the person who registers and 
                        lists the devices at issue under section 510.
                    ``(B) Compensation.--Compensation for such 
                accredited persons shall--
                            ``(i) be determined by agreement between 
                        the accredited person and the person who 
                        engages the services of the accredited person; 
                        and
                            ``(ii) be paid by the person who engages 
                        such services.
                    ``(C) Accredited person selection.--Each person who 
                chooses to use an accredited person to assess a 
                requestor's quality system, as described in this 
                section, shall select the accredited person from a list 
                of such persons published by the Secretary in 
                accordance with section 704(g)(4).
            ``(5) Guidance; criteria for certification.--
                    ``(A) In general.--The criteria for certification 
                of a quality system under this section shall be as 
                specified by the Secretary in guidance issued under 
                this paragraph.
                    ``(B) Contents; certification criteria.--The 
                guidance under this paragraph shall include 
                specification of--
                            ``(i) evaluative criteria to be used by an 
                        accredited person to assess and as applicable 
                        certify a requestor's quality system under this 
                        section with respect to in-scope devices ; and
                            ``(ii) criteria for accredited persons to 
                        apply a waiver of and exemptions from the 
                        certification criteria under clause (i).
                    ``(C) Timeframe for issuing guidance.--The 
                Secretary shall issue under this paragraph--
                            ``(i) draft guidance not later than 12 
                        months after the enactment of the 21st Century 
                        Cures Act; and
                            ``(ii) final guidance not later than 12 
                        months after issuance of the draft guidance 
                        under clause (i).
    ``(b) Use of Third-Party Assessment.--
            ``(1) Assessment summary; certification.--
                    ``(A) Submission of assessment to secretary.--An 
                accredited person who assesses a requestor's quality 
                system under subsection (a) shall submit to the 
                Secretary a summary of the assessment--
                            ``(i) within 30 days of the assessment; and
                            ``(ii) which as applicable shall include--
                                    ``(I) the accredited person's 
                                certification that the requestor has 
                                satisfied the criteria issued under 
                                subsection (a)(5) for quality system 
                                certification with respect to the in-
                                scope devices at issue; and
                                    ``(II) any waivers or exemptions 
                                from such criteria applied by the 
                                accredited person.
                    ``(B) Treatment of assessments.--Subject to action 
                by the Secretary under subparagraph (C), with respect 
                to assessments which include a certification under this 
                section--
                            ``(i) the Secretary's review of the 
                        assessment summary shall be deemed complete on 
                        the day that is 30 days after the date on which 
                        the Secretary receives the summary under 
                        subparagraph (A); and
                            ``(ii) the assessment summary and 
                        certification of the requestor shall be deemed 
                        accepted by the Secretary on such 30th day.
                    ``(C) Actions by secretary.--
                            ``(i) In general.--Within 30 days of 
                        receiving an assessment summary and 
                        certification under subparagraph (A), the 
                        Secretary may, by written notice to the 
                        accredited person submitting such assessment 
                        certification, deem any such certification to 
                        be provisional beyond such 30-day period, 
                        suspended pending further review by the 
                        Secretary, or otherwise qualified or cancelled, 
                        based on the Secretary's determination that (as 
                        applicable)--
                                    ``(I) additional information is 
                                needed to support such certification;
                                    ``(II) such assessment or 
                                certification is unwarranted; or
                                    ``(III) such action with regard to 
                                the certification is otherwise 
                                justified according to such factors and 
                                criteria as the Secretary finds 
                                appropriate.
                            ``(ii) Acceptance of certification.--If 
                        following action by the Secretary under clause 
                        (i) with respect to a certification, the 
                        Secretary determines that such certification is 
                        acceptable, the Secretary shall issue written 
                        notice to the applicable accredited person 
                        indicating such acceptance.
            ``(2) Notifications to secretary by certified manufacturers 
        for program evaluation purposes.--
                    ``(A) Periodic notification for manufacturing 
                changes otherwise subject to thirty-day notice.--A 
                requestor certified under this section that effectuates 
                device-related changes with respect to in-scope 
                devices, without prior submission of a thirty-day 
                notice, shall provide notification to the Secretary of 
                such changes in the requestor's next periodic report 
                under section 814.84(b) of title 21, Code of Federal 
                Regulations (or any successor regulation). Such 
                notification shall--
                            ``(i) describe the changes made; and
                            ``(ii) indicate the effective dates of such 
                        changes.
                    ``(B) Periodic notification for device-related 
                changes otherwise subject to special pma supplement.--A 
                requestor certified under this section that effectuates 
                device-related changes with respect to in-scope 
                devices, without prior submission of a Special PMA 
                Supplement, shall provide notification to the Secretary 
                of such changes in the requestor's next periodic report 
                under section 814.84(b) of title 21, Code of Federal 
                Regulations (or any successor regulation). Such 
                notification shall--
                            ``(i) describe the changes made, including 
                        a full explanation of the basis for the 
                        changes; and
                            ``(ii) indicate the effective dates of such 
                        changes.
                    ``(C) Use of notifications for program evaluation 
                purposes.--Information submitted to the Secretary under 
                subparagraphs (A) and (B) shall be used by the 
                Secretary for purposes of the program evaluation under 
                subsection (d).
    ``(c) Duration and Effect of Certification.--A certification under 
this section--
            ``(1) shall remain in effect for a period of two years from 
        the date such certification is accepted by the Secretary, 
        subject to paragraph (6);
            ``(2) may be renewed through the process described in 
        subsection (a)(3);
            ``(3) shall continue to apply with respect to device-
        related changes made during such 2-year period, provided the 
        certification remains in effect, irrespective of whether such 
        certification is renewed after such 2-year period;
            ``(4) shall have no effect on the need to comply with 
        applicable submission requirements specified in subsection 
        (a)(1)(C) with respect to any change pertaining to in-scope 
        devices which is not a device-related change under subsection 
        (a)(2);
            ``(5) shall have no effect on the authority of the 
        Secretary to conduct an inspection or otherwise determine the 
        requestor's conformance with the applicable requirements of 
        this Act; and
            ``(6) shall be considered to be revoked if the Secretary 
        provides written notification to the certified requestor that 
        its quality system does not satisfy the certification criteria 
        issued under subsection (a)(5) with respect to the in-scope 
        devices at issue, such that the applicable submission 
        requirements specified in subsection (a)(1)(C) must be met for 
        changes made after receipt of such written notification, with 
        respect to such devices.
    ``(d) Program Evaluation; Sunset.--
            ``(1) Program evaluation and report.--
                    ``(A) Evaluation.--The Secretary shall complete an 
                evaluation of the third-party quality system assessment 
                program under this section no later than January 31, 
                2021, based on--
                            ``(i) analysis of information from a 
                        representative group of device manufacturers 
                        obtained from notifications provided by 
                        certified requestors under subsection (b)(2); 
                        and
                            ``(ii) such other available information and 
                        data as the Secretary determines appropriate.
                    ``(B) Report.--No later than 1 year after 
                completing the evaluation under subparagraph (A), the 
                Secretary shall issue a report of the evaluation's 
                findings on the website of the Food and Drug 
                Administration, which shall include the Secretary's 
                recommendations with respect to continuation and as 
                applicable expansion of the program under this section 
                to include additional types of submissions and 
                additional types of changes beyond those identified in 
                subsection (a)(1)(C), including changes to devices 
                cleared under section 510(k). At the discretion of the 
                Secretary, the program may be expanded prior to January 
                31, 2021.
            ``(2) Sunset.--This section shall cease to be effective 
        October 1, 2022.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed to limit the authority of the Secretary to request and review 
the complete assessment of a certified requestor under this section on 
a for-cause basis.''.
    (b) Conforming Amendments.--
            (1) Requirements for premarket approval supplements.--
        Section 515(d)(6)(A)(i) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ``, 
        subject to section 524B,'' after ``that affects safety or 
        effectiveness''.
            (2) Requirements for thirty-day notice.--Section 
        515(d)(6)(A)(ii) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360e(d)(6)(A)(ii)) is amended by inserting ``, 
        subject to section 524B,'' after ``the date on which the 
        Secretary receives the notice''.
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