I 

114TH CONGRESS 

1ST SESSION H. R. 2422 

To amend the Federal Food, Drug, and Cosmetic Act with respect to thirdparty 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. 

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

3 SECTION 1. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 

4 (a) ESTABLISHMENT OF THIRD-PARTY QUALITY

5 SYSTEM ASSESSMENT PROGRAM.—Chapter V of the Fed6 eral Food, Drug, and Cosmetic Act is amended by insert7 ing after section 524A (21 U.S.C. 360n–1) the following 

8 new section: 

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

10 ‘‘(a) ACCREDITATION AND ASSESSMENT.— 


SSpencer on DSK4SPTVN1PROD with BILLS
2 

•HR 2422 IH

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

2 QUALITY SYSTEM.—The Secretary shall, in accord3 ance with this section, establish a third-party quality 

4 system assessment program— 

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

6 a requestor’s quality system, including its de7 sign controls, can reasonably assure the safety 

8 and effectiveness of in-scope devices subject to 

9 device-related changes (as defined in paragraph 

10 (2)); 

11 ‘‘(B) under which accredited persons shall, 

12 as applicable, certify that a requestor’s quality 

13 system meets the criteria issued under para14 graph (5) with respect to the in-scope devices at 

15 issue; and 

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

17 on such certifications for purposes of deter18 mining the safety and effectiveness of in-scope 

19 devices subject to the device-related changes in20 volved, in lieu of compliance with the following 

21 submission requirements: 

22 ‘‘(i) A thirty-day notice (as defined in 

23 paragraph (2)). 

24 ‘‘(ii) A Special PMA supplement (as 

25 defined in paragraph (2)). 


SSpencer on DSK4SPTVN1PROD with BILLS
3 

•HR 2422 IH

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

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) manufacturing changes subject to 

7 a 30-day notice; 

8 ‘‘(ii) changes that qualify for a Spe9 cial PMA supplement; and 

10 ‘‘(iii) such other changes relating to 

11 the devices or the device manufacturing 

12 process as the Secretary determines appro13 priate; 

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

15 device within the scope of devices agreed to by 

16 the requestor and the accredited person for pur17 poses of a request for certification under this 

18 section; 

19 ‘‘(C) the term ‘quality system’ means a 

20 quality system described in section 520(f); 

21 ‘‘(D) the term ‘requestor’ means a device 

22 manufacturer that is seeking certification under 

23 this section of a quality system used by such 

24 manufacturer; 


SSpencer on DSK4SPTVN1PROD with BILLS
4 

•HR 2422 IH

1 ‘‘(E) the term ‘Special PMA’ means a Spe2 cial PMA supplement under section 814.39(d) 

3 of title 21, Code of Federal Regulations (or any 

4 successor regulations); and 

5 ‘‘(F) the term ‘thirty-day notice’ means a 

6 notice described in section 515(d)(6). 

7 ‘‘(3) ACCREDITATION PROCESS; ACCREDITATION

8 RENEWAL.—Except as inconsistent with this section, 

9 the process and qualifications for accreditation of 

10 persons and renewal of such accreditation under sec11 tion 704(g) shall apply with respect to accreditation 

12 of persons and renewal of such accreditation under 

13 this section. 

14 ‘‘(4) USE OF ACCREDITED PARTIES TO CON15 DUCT ASSESSMENTS.— 

16 ‘‘(A) INITIATION OF ASSESSMENT SERV17 ICES.— 

18 ‘‘(i) DATE ASSESSMENTS AUTHOR19 IZED.—Beginning after issuance of the 

20 final guidance under paragraph (5), an ac21 credited person may conduct an assess22 ment under this section. 

23 ‘‘(ii) INITIATION OF ASSESSMENTS.— 

24 Use of one or more accredited persons to 

25 assess a requestor’s quality system under 


SSpencer on DSK4SPTVN1PROD with BILLS
5 

•HR 2422 IH

1 this section with respect to in-scope devices 

2 shall be at the initiation of the person who 

3 registers and lists the devices at issue 

4 under section 510. 

5 ‘‘(B) COMPENSATION.—Compensation for 

6 such accredited persons shall— 

7 ‘‘(i) be determined by agreement be8 tween the accredited person and the person 

9 who engages the services of the accredited 

10 person; and 

11 ‘‘(ii) be paid by the person who en12 gages such services. 

13 ‘‘(C) ACCREDITED PERSON SELECTION.— 

14 Each person who chooses to use an accredited 

15 person to assess a requestor’s quality system, 

16 as described in this section, shall select the ac17 credited person from a list of such persons pub18 lished by the Secretary in accordance with sec19 tion 704(g)(4). 

20 ‘‘(5) GUIDANCE; CRITERIA FOR CERTIFI21 CATION.— 

22 ‘‘(A) IN GENERAL.—The criteria for cer23 tification of a quality system under this section 

24 shall be as specified by the Secretary in guid25 ance issued under this paragraph. 


SSpencer on DSK4SPTVN1PROD with BILLS
6 

•HR 2422 IH

1 ‘‘(B) CONTENTS; CERTIFICATION CRI2 TERIA.—The guidance under this paragraph 

3 shall include specification of— 

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

5 an accredited person to assess and as ap6 plicable certify a requestor’s quality system 

7 under this section with respect to in-scope 

8 devices ; and 

9 ‘‘(ii) criteria for accredited persons to 

10 apply a waiver of and exemptions from the 

11 certification criteria under clause (i). 

12 ‘‘(C) TIMEFRAME FOR ISSUING GUID13 ANCE.—The Secretary shall issue under this 

14 paragraph— 

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

16 months after the enactment of the 21st 

17 Century Cures Act; and 

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

19 months after issuance of the draft guid20 ance under clause (i). 

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

22 ‘‘(1) ASSESSMENT SUMMARY; CERTIFI23 CATION.— 

24 ‘‘(A) SUBMISSION OF ASSESSMENT TO SEC25 RETARY.—An accredited person who assesses a 


SSpencer on DSK4SPTVN1PROD with BILLS
7 

•HR 2422 IH

1 requestor’s quality system under subsection (a) 

2 shall submit to the Secretary a summary of the 

3 assessment— 

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

5 and 

6 ‘‘(ii) which as applicable shall in7 clude— 

8 ‘‘(I) the accredited person’s cer9 tification that the requestor has satis10 fied the criteria issued under sub11 section (a)(5) for quality system cer12 tification with respect to the in-scope 

13 devices at issue; and 

14 ‘‘(II) any waivers or exemptions 

15 from such criteria applied by the ac16 credited person. 

17 ‘‘(B) TREATMENT OF ASSESSMENTS.— 

18 Subject to action by the Secretary under sub19 paragraph (C), with respect to assessments 

20 which include a certification under this sec21 tion— 

22 ‘‘(i) the Secretary’s review of the as23 sessment summary shall be deemed com24 plete on the day that is 30 days after the 


SSpencer on DSK4SPTVN1PROD with BILLS
8 

•HR 2422 IH

1 date on which the Secretary receives the 

2 summary under subparagraph (A); and 

3 ‘‘(ii) the assessment summary and 

4 certification of the requestor shall be 

5 deemed accepted by the Secretary on such 

6 30th day. 

7 ‘‘(C) ACTIONS BY SECRETARY.— 

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

9 receiving an assessment summary and cer10 tification under subparagraph (A), the Sec11 retary may, by written notice to the ac12 credited person submitting such assess13 ment certification, deem any such certifi14 cation to be provisional beyond such 30- 

15 day period, suspended pending further re16 view by the Secretary, or otherwise quali17 fied or cancelled, based on the Secretary’s 

18 determination that (as applicable)— 

19 ‘‘(I) additional information is 

20 needed to support such certification; 

21 ‘‘(II) such assessment or certifi22 cation is unwarranted; or 

23 ‘‘(III) such action with regard to 

24 the certification is otherwise justified 


SSpencer on DSK4SPTVN1PROD with BILLS
9 

•HR 2422 IH

1 according to such factors and criteria 

2 as the Secretary finds appropriate. 

3 ‘‘(ii) ACCEPTANCE OF CERTIFI4 CATION.—If following action by the Sec5 retary under clause (i) with respect to a 

6 certification, the Secretary determines that 

7 such certification is acceptable, the Sec8 retary shall issue written notice to the ap9 plicable accredited person indicating such 

10 acceptance. 

11 ‘‘(2) NOTIFICATIONS TO SECRETARY BY CER12 TIFIED MANUFACTURERS FOR PROGRAM EVALUA13 TION PURPOSES.— 

14 ‘‘(A) PERIODIC NOTIFICATION FOR MANU15 FACTURING CHANGES OTHERWISE SUBJECT TO

16 THIRTY-DAY NOTICE.—A requestor certified 

17 under this section that effectuates device-re18 lated changes with respect to in-scope devices, 

19 without prior submission of a thirty-day notice, 

20 shall provide notification to the Secretary of 

21 such changes in the requestor’s next periodic 

22 report under section 814.84(b) of title 21, Code 

23 of Federal Regulations (or any successor regu24 lation). Such notification shall— 

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


SSpencer on DSK4SPTVN1PROD with BILLS
10 

•HR 2422 IH

1 ‘‘(ii) indicate the effective dates of 

2 such changes. 

3 ‘‘(B) PERIODIC NOTIFICATION FOR DE4 VICE-RELATED CHANGES OTHERWISE SUBJECT

5 TO SPECIAL PMA SUPPLEMENT.—A requestor 

6 certified under this section that effectuates de7 vice-related changes with respect to in-scope de8 vices, without prior submission of a Special 

9 PMA Supplement, shall provide notification to 

10 the Secretary of such changes in the requestor’s 

11 next periodic report under section 814.84(b) of 

12 title 21, Code of Federal Regulations (or any 

13 successor regulation). Such notification shall— 

14 ‘‘(i) describe the changes made, in15 cluding a full explanation of the basis for 

16 the changes; and 

17 ‘‘(ii) indicate the effective dates of 

18 such changes. 

19 ‘‘(C) USE OF NOTIFICATIONS FOR PRO20 GRAM EVALUATION PURPOSES.—Information 

21 submitted to the Secretary under subpara22 graphs (A) and (B) shall be used by the Sec23 retary for purposes of the program evaluation 

24 under subsection (d). 


SSpencer on DSK4SPTVN1PROD with BILLS
11 

•HR 2422 IH

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

2 A certification under this section— 

3 ‘‘(1) shall remain in effect for a period of two 

4 years from the date such certification is accepted by 

5 the Secretary, subject to paragraph (6); 

6 ‘‘(2) may be renewed through the process de7 scribed in subsection (a)(3); 

8 ‘‘(3) shall continue to apply with respect to de9 vice-related changes made during such 2-year period, 

10 provided the certification remains in effect, irrespec11 tive of whether such certification is renewed after 

12 such 2-year period; 

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

14 with applicable submission requirements specified in 

15 subsection (a)(1)(C) with respect to any change per16 taining to in-scope devices which is not a device-re17 lated change under subsection (a)(2); 

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

19 Secretary to conduct an inspection or otherwise de20 termine the requestor’s conformance with the appli21 cable requirements of this Act; and 

22 ‘‘(6) shall be considered to be revoked if the 

23 Secretary provides written notification to the cer24 tified requestor that its quality system does not sat25 isfy the certification criteria issued under subsection 


SSpencer on DSK4SPTVN1PROD with BILLS
12 

•HR 2422 IH

1 (a)(5) with respect to the in-scope devices at issue, 

2 such that the applicable submission requirements 

3 specified in subsection (a)(1)(C) must be met for 

4 changes made after receipt of such written notifica5 tion, with respect to such devices. 

6 ‘‘(d) PROGRAM EVALUATION; SUNSET.— 

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

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

9 complete an evaluation of the third-party qual10 ity system assessment program under this sec11 tion no later than January 31, 2021, based 

12 on— 

13 ‘‘(i) analysis of information from a 

14 representative group of device manufactur15 ers obtained from notifications provided by 

16 certified requestors under subsection 

17 (b)(2); and 

18 ‘‘(ii) such other available information 

19 and data as the Secretary determines ap20 propriate. 

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

22 completing the evaluation under subparagraph 

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

24 evaluation’s findings on the website of the Food 

25 and Drug Administration, which shall include 


SSpencer on DSK4SPTVN1PROD with BILLS
13 

•HR 2422 IH

1 the Secretary’s recommendations with respect 

2 to continuation and as applicable expansion of 

3 the program under this section to include addi4 tional types of submissions and additional types 

5 of changes beyond those identified in subsection 

6 (a)(1)(C), including changes to devices cleared 

7 under section 510(k). At the discretion of the 

8 Secretary, the program may be expanded prior 

9 to January 31, 2021. 

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

11 effective October 1, 2022. 

12 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed to limit the authority of the Sec14 retary to request and review the complete assessment of 

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

16 basis.’’. 

17 (b) CONFORMING AMENDMENTS.— 

18 (1) REQUIREMENTS FOR PREMARKET AP19 PROVAL SUPPLEMENTS.—Section 515(d)(6)(A)(i) of 

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

21 U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ‘‘, 

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

23 or effectiveness’’. 

24 (2) REQUIREMENTS FOR THIRTY-DAY NO25 TICE.—Section 515(d)(6)(A)(ii) of the Federal 


SSpencer on DSK4SPTVN1PROD with BILLS
14 

•HR 2422 IH

1 Food, Drug, and Cosmetic Act (21 U.S.C. 

2 360e(d)(6)(A)(ii)) is amended by inserting ‘‘, subject 

3 to section 524B,’’ after ‘‘the date on which the Sec4 retary receives the notice’’. 

Æ 


SSpencer on DSK4SPTVN1PROD with BILLS