[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2187 Introduced in Senate (IS)]

<DOC>






114th CONGRESS
  1st Session
                                S. 2187

     To establish a third-party quality system assessment program.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 21, 2015

  Mr. Donnelly (for himself and Mr. Gardner) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
     To establish a third-party quality system assessment program.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Regulatory Efficiency Act''.

SEC. 2. 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:

``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;
                    ``(B) under which accredited persons shall (as 
                applicable) certify that a requestor's quality system 
                meets the criteria included in the guidance 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 (or as applicable, substantial 
                equivalence) of in-scope devices subject to the device-
                related changes involved, in lieu of compliance with 
                the following submission requirements:
                            ``(i) A premarket notification.
                            ``(ii) A 30-day notice.
                            ``(iii) A Special PMA supplement.
            ``(2) Definitions.--For purposes of this section--
                    ``(A) the term `device-related changes' means 
                changes made by a requestor with respect to in-scope 
                devices, which are--
                            ``(i) changes to a device found to be 
                        substantially equivalent under subsections 
                        (f)(1) and (i) of section 513 to a predicate 
                        device, that--
                                    ``(I) would otherwise be subject to 
                                a premarket notification; and
                                    ``(II) do not alter--
                                            ``(aa) the intended use of 
                                        the changed device; or
                                            ``(bb) the fundamental 
                                        scientific technology of such 
                                        device;
                            ``(ii) manufacturing changes subject to a 
                        30-day notice;
                            ``(iii) changes that qualify for a Special 
                        PMA Supplement; and
                            ``(iv) 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 `premarket notification' means a 
                premarket notification under section 510(k);
                    ``(D) the term `quality system' means the methods 
                used in, and the facilities and controls used for, the 
                design, manufacture, packaging, labeling, storage, 
                installation, and servicing of devices, as described in 
                section 520(f);
                    ``(E) the term `requestor' means a device 
                manufacturer that is seeking certification under this 
                section of a quality system used by such manufacturer;
                    ``(F) the term `Special PMA' means a PMA supplement 
                under section 814.39(d) of title 21, Code of Federal 
                Regulations (or any successor regulations); and
                    ``(G) the term `30-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 the date on which the final 
                        guidance is issued 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; 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 for a waiver of, and exemptions from, the 
                        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 FDA 
                        Regulatory Efficiency 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 shall include (as 
                        applicable)--
                                    ``(I) the accredited person's 
                                certification that the requestor has 
                                satisfied the criteria specified in the 
                                guidance 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 quality system of a 
                        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 requestors or 
        accredited persons for program evaluation purposes.--
                    ``(A) Annual summary report for device-related 
                changes otherwise subject to premarket notification.--A 
                requestor whose quality system is certified under this 
                section that effectuates device-related changes with 
                respect to in-scope devices, without prior submission 
                of a premarket notification, shall ensure that an 
                annual summary report is submitted to the Secretary by 
                the accredited person which--
                            ``(i) describes the changes made to the in-
                        scope device; and
                            ``(ii) indicates the effective dates of 
                        such changes.
                    ``(B) Periodic notification for manufacturing 
                changes otherwise subject to 30-day notice.--A 
                requestor whose quality system is certified under this 
                section that effectuates device-related changes with 
                respect to in-scope devices, without prior submission 
                of a 30-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.
                    ``(C) Periodic notification for device-related 
                changes otherwise subject to special pma supplement.--A 
                requestor whose quality system is 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.
                    ``(D) Use of notifications for program evaluation 
                purposes.--Information submitted to the Secretary under 
                subparagraphs (A) through (C) 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 2 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 
        whether the requestor has complied with the applicable 
        requirements of this Act; and
            ``(6) may be revoked by the Secretary upon a determination 
        that the requestor's quality system no longer meets the 
        criteria specified in the guidance issued under subsection 
        (a)(5) with respect to the in-scope devices at issue.
    ``(d) Notice of Revocation.--The Secretary shall provide written 
notification to the requestor of a revocation pursuant to subsection 
(c)(6) not later than 10 business days after the determination 
described in such subsection. Upon receipt of the written notification, 
the requestor shall satisfy the applicable submission requirements 
specified in subsection (a)(1)(C) for any device-related changes 
effectuated after the date of such determination. After such 
revocation, such requestor is eligible to seek re-certification under 
this section of its quality system.
    ``(e) 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 or accredited persons 
                        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 encompass--
                            ``(i) device submissions beyond those 
                        identified in subsection (a)(1)(C); and
                            ``(ii) device changes beyond those 
                        described in subsection (a)(2)(A).
            ``(2) Sunset.--This section shall cease to be effective 
        October 1, 2022.
    ``(f) 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)(5)(A)(i)) is amended by inserting 
        ``subject to section 524B,'' after ``that affects safety or 
        effectiveness,''.
            (2) Requirements for 30-day notice.--Section 
        515(d)(6)(A)(ii) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360e(d)(5)(A)(ii)) is amended by inserting ``subject 
        to section 524B,'' after ``the date on which the Secretary 
        receives the notice,''.
            (3) Requirements for premarket notification; technical 
        correction to reference to section 510(k).--Section 510(l) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
        amended by striking ``of this subsection under subsection (m)'' 
        and inserting ``of subsection (k) under subsection (m) or 
        section 524B''.
            (4) Misbranded devices.--Section 502(t) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by 
        inserting ``or 524B'' after ``section 519''.
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