II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Regulatory Effi5 ciency Act’’. 

6 SEC. 2. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 

7 (a) ESTABLISHMENT OF THIRD-PARTY QUALITY

8 SYSTEM ASSESSMENT PROGRAM.—Chapter V of the Fed9 eral Food, Drug, and Cosmetic Act is amended by insert10 ing after section 524A (21 U.S.C. 360n–1) the following: 


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1 ‘‘SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 

2 ‘‘(a) ACCREDITATION AND ASSESSMENT.— 

3 ‘‘(1) IN GENERAL; CERTIFICATION OF DEVICE

4 QUALITY SYSTEM.—The Secretary shall, in accord5 ance with this section, establish a third-party quality 

6 system assessment program— 

7 ‘‘(A) to accredit persons to assess whether 

8 a requestor’s quality system, including its de9 sign controls, can reasonably assure the safety 

10 and effectiveness of in-scope devices subject to 

11 device-related changes; 

12 ‘‘(B) under which accredited persons shall 

13 (as applicable) certify that a requestor’s quality 

14 system meets the criteria included in the guid15 ance issued under paragraph (5) with respect to 

16 the in-scope devices at issue; and 

17 ‘‘(C) under which the Secretary shall rely 

18 on such certifications for purposes of deter19 mining the safety and effectiveness (or as appli20 cable, substantial equivalence) of in-scope de21 vices subject to the device-related changes in22 volved, in lieu of compliance with the following 

23 submission requirements: 

24 ‘‘(i) A premarket notification. 

25 ‘‘(ii) A 30-day notice. 

26 ‘‘(iii) A Special PMA supplement. 


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1 ‘‘(2) DEFINITIONS.—For purposes of this sec2 tion— 

3 ‘‘(A) the term ‘device-related changes’ 

4 means changes made by a requestor with re5 spect to in-scope devices, which are— 

6 ‘‘(i) changes to a device found to be 

7 substantially equivalent under subsections 

8 (f)(1) and (i) of section 513 to a predicate 

9 device, that— 

10 ‘‘(I) would otherwise be subject 

11 to a premarket notification; and 

12 ‘‘(II) do not alter— 

13 ‘‘(aa) the intended use of 

14 the changed device; or 

15 ‘‘(bb) the fundamental sci16 entific technology of such device; 

17 ‘‘(ii) manufacturing changes subject 

18 to a 30-day notice; 

19 ‘‘(iii) changes that qualify for a Spe20 cial PMA Supplement; and 

21 ‘‘(iv) such other changes relating to 

22 the devices or the device manufacturing 

23 process as the Secretary determines appro24 priate; 


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1 ‘‘(B) the term ‘in-scope device’ means a 

2 device within the scope of devices agreed to by 

3 the requestor and the accredited person for pur4 poses of a request for certification under this 

5 section; 

6 ‘‘(C) the term ‘premarket notification’ 

7 means a premarket notification under section 

8 510(k); 

9 ‘‘(D) the term ‘quality system’ means the 

10 methods used in, and the facilities and controls 

11 used for, the design, manufacture, packaging, 

12 labeling, storage, installation, and servicing of 

13 devices, as described in section 520(f); 

14 ‘‘(E) the term ‘requestor’ means a device 

15 manufacturer that is seeking certification under 

16 this section of a quality system used by such 

17 manufacturer; 

18 ‘‘(F) the term ‘Special PMA’ means a 

19 PMA supplement under section 814.39(d) of 

20 title 21, Code of Federal Regulations (or any 

21 successor regulations); and 

22 ‘‘(G) the term ‘30-day notice’ means a no23 tice described in section 515(d)(6). 

24 ‘‘(3) ACCREDITATION PROCESS; ACCREDITATION

25 RENEWAL.—Except as inconsistent with this section, 


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1 the process and qualifications for accreditation of 

2 persons and renewal of such accreditation under sec3 tion 704(g) shall apply with respect to accreditation 

4 of persons and renewal of such accreditation under 

5 this section. 

6 ‘‘(4) USE OF ACCREDITED PARTIES TO CON7 DUCT ASSESSMENTS.— 

8 ‘‘(A) INITIATION OF ASSESSMENT SERV9 ICES.— 

10 ‘‘(i) DATE ASSESSMENTS AUTHOR11 IZED.—Beginning after the date on which 

12 the final guidance is issued under para13 graph (5), an accredited person may con14 duct an assessment under this section. 

15 ‘‘(ii) INITIATION OF ASSESSMENTS.— 

16 Use of one or more accredited persons to 

17 assess a requestor’s quality system under 

18 this section with respect to in-scope devices 

19 shall be at the initiation of the person who 

20 registers and lists the devices at issue 

21 under section 510. 

22 ‘‘(B) COMPENSATION.—Compensation for 

23 such accredited persons shall— 

24 ‘‘(i) be determined by agreement be25 tween the accredited person and the person 


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1 who engages the services of the accredited 

2 person; and 

3 ‘‘(ii) be paid by the person who en4 gages such services. 

5 ‘‘(C) ACCREDITED PERSON SELECTION.— 

6 Each person who chooses to use an accredited 

7 person to assess a requestor’s quality system, 

8 as described in this section, shall select the ac9 credited person from a list of such persons pub10 lished by the Secretary in accordance with sec11 tion 704(g)(4). 

12 ‘‘(5) GUIDANCE; CRITERIA FOR CERTIFI13 CATION.— 

14 ‘‘(A) IN GENERAL.—The criteria for cer15 tification of a quality system under this section 

16 shall be as specified by the Secretary in guid17 ance issued under this paragraph. 

18 ‘‘(B) CONTENTS; CRITERIA.—The guidance 

19 under this paragraph shall include specification 

20 of— 

21 ‘‘(i) evaluative criteria to be used by 

22 an accredited person to assess and, as ap23 plicable, certify a requestor’s quality sys24 tem under this section with respect to in25 scope devices; and 


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1 ‘‘(ii) criteria for accredited persons to 

2 apply for a waiver of, and exemptions 

3 from, the criteria under clause (i). 

4 ‘‘(C) TIMEFRAME FOR ISSUING GUID5 ANCE.—The Secretary shall issue under this 

6 paragraph— 

7 ‘‘(i) draft guidance not later than 12 

8 months after the enactment of the FDA 

9 Regulatory Efficiency Act; and 

10 ‘‘(ii) final guidance not later than 12 

11 months after issuance of the draft guid12 ance under clause (i). 

13 ‘‘(b) USE OF THIRD-PARTY ASSESSMENT.— 

14 ‘‘(1) ASSESSMENT SUMMARY; CERTIFI15 CATION.— 

16 ‘‘(A) SUBMISSION OF ASSESSMENT TO SEC17 RETARY.—An accredited person who assesses a 

18 requestor’s quality system under subsection (a) 

19 shall submit to the Secretary a summary of the 

20 assessment— 

21 ‘‘(i) within 30 days of the assessment; 

22 and 

23 ‘‘(ii) which shall include (as applica24 ble)— 


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1 ‘‘(I) the accredited person’s cer2 tification that the requestor has satis3 fied the criteria specified in the guid4 ance issued under subsection (a)(5) 

5 for quality system certification with 

6 respect to the in-scope devices at 

7 issue; and 

8 ‘‘(II) any waivers or exemptions 

9 from such criteria applied by the ac10 credited person. 

11 ‘‘(B) TREATMENT OF ASSESSMENTS.— 

12 Subject to action by the Secretary under sub13 paragraph (C), with respect to assessments 

14 which include a certification under this sec15 tion— 

16 ‘‘(i) the Secretary’s review of the as17 sessment summary shall be deemed com18 plete on the day that is 30 days after the 

19 date on which the Secretary receives the 

20 summary under subparagraph (A); and 

21 ‘‘(ii) the assessment summary and 

22 certification of the quality system of a re23 questor shall be deemed accepted by the 

24 Secretary on such 30th day. 

25 ‘‘(C) ACTIONS BY SECRETARY.— 


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1 ‘‘(i) IN GENERAL.—Within 30 days of 

2 receiving an assessment summary and cer3 tification under subparagraph (A), the Sec4 retary may, by written notice to the ac5 credited person submitting such assess6 ment certification, deem any such certifi7 cation to be provisional beyond such 30- 

8 day period, suspended pending further re9 view by the Secretary, or otherwise quali10 fied or cancelled, based on the Secretary’s 

11 determination that (as applicable)— 

12 ‘‘(I) additional information is 

13 needed to support such certification; 

14 ‘‘(II) such assessment or certifi15 cation is unwarranted; or 

16 ‘‘(III) such action with regard to 

17 the certification is otherwise justified 

18 according to such factors and criteria 

19 as the Secretary finds appropriate. 

20 ‘‘(ii) ACCEPTANCE OF CERTIFI21 CATION.—If following action by the Sec22 retary under clause (i) with respect to a 

23 certification, the Secretary determines that 

24 such certification is acceptable, the Sec25 retary shall issue written notice to the apVerDate Sep 11 2014 00:17 Oct 22, 2015 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2187.IS S2187

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1 plicable accredited person indicating such 

2 acceptance. 

3 ‘‘(2) NOTIFICATIONS TO SECRETARY BY CER4 TIFIED REQUESTORS OR ACCREDITED PERSONS FOR

5 PROGRAM EVALUATION PURPOSES.— 

6 ‘‘(A) ANNUAL SUMMARY REPORT FOR DE7 VICE-RELATED CHANGES OTHERWISE SUBJECT

8 TO PREMARKET NOTIFICATION.—A requestor 

9 whose quality system is certified under this sec10 tion that effectuates device-related changes with 

11 respect to in-scope devices, without prior sub12 mission of a premarket notification, shall en13 sure that an annual summary report is sub14 mitted to the Secretary by the accredited per15 son which— 

16 ‘‘(i) describes the changes made to the 

17 in-scope device; and 

18 ‘‘(ii) indicates the effective dates of 

19 such changes. 

20 ‘‘(B) PERIODIC NOTIFICATION FOR MANU21 FACTURING CHANGES OTHERWISE SUBJECT TO

22 30-DAY NOTICE.—A requestor whose quality 

23 system is certified under this section that effec24 tuates device-related changes with respect to in25 scope devices, without prior submission of a 30- 


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1 day notice, shall provide notification to the Sec2 retary of such changes in the requestor’s next 

3 periodic report under section 814.84(b) of title 

4 21, Code of Federal Regulations (or any suc5 cessor regulation). Such notification shall— 

6 ‘‘(i) describe the changes made; and 

7 ‘‘(ii) indicate the effective dates of 

8 such changes. 

9 ‘‘(C) PERIODIC NOTIFICATION FOR DE10 VICE-RELATED CHANGES OTHERWISE SUBJECT

11 TO SPECIAL PMA SUPPLEMENT.—A requestor 

12 whose quality system is certified under this sec13 tion that effectuates device-related changes with 

14 respect to in-scope devices, without prior sub15 mission of a Special PMA Supplement, shall 

16 provide notification to the Secretary of such 

17 changes in the requestor’s next periodic report 

18 under section 814.84(b) of title 21, Code of 

19 Federal Regulations (or any successor regula20 tion). Such notification shall— 

21 ‘‘(i) describe the changes made, in22 cluding a full explanation of the basis for 

23 the changes; and 

24 ‘‘(ii) indicate the effective dates of 

25 such changes. 


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1 ‘‘(D) USE OF NOTIFICATIONS FOR PRO2 GRAM EVALUATION PURPOSES.—Information 

3 submitted to the Secretary under subpara4 graphs (A) through (C) shall be used by the 

5 Secretary for purposes of the program evalua6 tion under subsection (d). 

7 ‘‘(c) DURATION AND EFFECT OF CERTIFICATION.— 

8 A certification under this section— 

9 ‘‘(1) shall remain in effect for a period of 2 

10 years from the date such certification is accepted by 

11 the Secretary, subject to paragraph (6); 

12 ‘‘(2) may be renewed through the process de13 scribed in subsection (a)(3); 

14 ‘‘(3) shall continue to apply with respect to de15 vice-related changes made during such 2-year period, 

16 provided the certification remains in effect, irrespec17 tive of whether such certification is renewed after 

18 such 2-year period; 

19 ‘‘(4) shall have no effect on the need to comply 

20 with applicable submission requirements specified in 

21 subsection (a)(1)(C) with respect to any change per22 taining to in-scope devices which is not a device-re23 lated change under subsection (a)(2); 

24 ‘‘(5) shall have no effect on the authority of the 

25 Secretary to conduct an inspection or otherwise deVerDate Sep 11 2014 00:17 Oct 22, 2015 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2187.IS S2187

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1 termine whether the requestor has complied with the 

2 applicable requirements of this Act; and 

3 ‘‘(6) may be revoked by the Secretary upon a 

4 determination that the requestor’s quality system no 

5 longer meets the criteria specified in the guidance 

6 issued under subsection (a)(5) with respect to the 

7 in-scope devices at issue. 

8 ‘‘(d) NOTICE OF REVOCATION.—The Secretary shall 

9 provide written notification to the requestor of a revoca10 tion pursuant to subsection (c)(6) not later than 10 busi11 ness days after the determination described in such sub12 section. Upon receipt of the written notification, the re13 questor shall satisfy the applicable submission require14 ments specified in subsection (a)(1)(C) for any device-re15 lated changes effectuated after the date of such deter16 mination. After such revocation, such requestor is eligible 

17 to seek re-certification under this section of its quality sys18 tem. 

19 ‘‘(e) PROGRAM EVALUATION; SUNSET.— 

20 ‘‘(1) PROGRAM EVALUATION AND REPORT.— 

21 ‘‘(A) EVALUATION.—The Secretary shall 

22 complete an evaluation of the third-party qual23 ity system assessment program under this sec24 tion no later than January 31, 2021, based 

25 on— 


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1 ‘‘(i) analysis of information from a 

2 representative group of device manufactur3 ers obtained from notifications provided by 

4 certified requestors or accredited persons 

5 under subsection (b)(2); and 

6 ‘‘(ii) such other available information 

7 and data as the Secretary determines ap8 propriate. 

9 ‘‘(B) REPORT.—No later than 1 year after 

10 completing the evaluation under subparagraph 

11 (A), the Secretary shall issue a report of the 

12 evaluation’s findings on the website of the Food 

13 and Drug Administration, which shall include 

14 the Secretary’s recommendations with respect 

15 to continuation and as applicable expansion of 

16 the program under this section to encompass— 

17 ‘‘(i) device submissions beyond those 

18 identified in subsection (a)(1)(C); and 

19 ‘‘(ii) device changes beyond those de20 scribed in subsection (a)(2)(A). 

21 ‘‘(2) SUNSET.—This section shall cease to be 

22 effective October 1, 2022. 

23 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec24 tion shall be construed to limit the authority of the Sec25 retary to request and review the complete assessment of 


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1 a certified requestor under this section on a for-cause 

2 basis.’’. 

3 (b) CONFORMING AMENDMENTS.— 

4 (1) REQUIREMENTS FOR PREMARKET AP5 PROVAL SUPPLEMENTS.—Section 515(d)(6)(A)(i) of 

6 the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 360e(d)(5)(A)(i)) is amended by inserting 

8 ‘‘subject to section 524B,’’ after ‘‘that affects safety 

9 or effectiveness,’’. 

10 (2) REQUIREMENTS FOR 30-DAY NOTICE.—Sec11 tion 515(d)(6)(A)(ii) of the Federal Food, Drug, 

12 and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(ii)) is 

13 amended by inserting ‘‘subject to section 524B,’’ 

14 after ‘‘the date on which the Secretary receives the 

15 notice,’’. 

16 (3) REQUIREMENTS FOR PREMARKET NOTIFI17 CATION; TECHNICAL CORRECTION TO REFERENCE

18 TO SECTION 510(k).—Section 510(l) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 

20 amended by striking ‘‘of this subsection under sub21 section (m)’’ and inserting ‘‘of subsection (k) under 

22 subsection (m) or section 524B’’. 

23 (4) MISBRANDED DEVICES.—Section 502(t) of 

24 the Federal Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 352(t)) is amended by inserting ‘‘or 524B’’ 

2 after ‘‘section 519’’. 

Æ 


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