II 

Calendar No. 426 

114TH CONGRESS 

2D SESSION S. 1622 

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

IN THE SENATE OF THE UNITED STATES 

JUNE 18, 2015 

Mr. BURR (for himself, Mr. FRANKEN, Mr. KIRK, Mr. ENZI, and Mr. ALEXANDER) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

APRIL 18, 2016 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to devices. 

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 Device Account5 ability Act of 2015’’. 


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1 SEC. 2. ENSURING LEAST BURDENSOME MEANS OF EVALU2 ATING DEVICES. 

3 (a) TRAINING AND OVERSIGHT OF LEAST BURDEN4 SOME REQUIREMENTS.—Section 513 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 

6 adding at the end the following: 

7 ‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDEN8 SOME REQUIREMENTS.— 

9 ‘‘(1) TRAINING AND ASSESSMENT.—The Sec10 retary shall— 

11 ‘‘(A) ensure that each employee of the 

12 Food and Drug Administration who is involved 

13 in the review of premarket submissions, includ14 ing supervisors, receives training regarding the 

15 meaning and implementation of the least bur16 densome requirements under subsections 

17 (a)(3)(D) and (i)(1)(D) and section 515(c)(5); 

18 and 

19 ‘‘(B) periodically assess the implementa20 tion of the least burdensome requirements, in21 cluding the employee training under subpara22 graph (A) to ensure that the least burdensome 

23 requirements are fully and consistently applied. 

24 ‘‘(2) OMBUDSMAN AUDIT.—Not later than 180 

25 calendar days after the date of enactment of the 

26 FDA Device Accountability Act of 2015, the omVerDate Sep 11 2014 22:05 Apr 18, 2016 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6401 E:\BILLS\S1622.RS S1622

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1 budsman for any organizational unit of the Food 

2 and Drug Administration responsible for the pre3 market review of devices shall— 

4 ‘‘(A) conduct an audit of the training de5 scribed in paragraph (1)(A); 

6 ‘‘(B) include in such audit interviews of 

7 persons who are representatives of the device 

8 industry regarding their experience in the de9 vice premarket review process, including with 

10 respect to the application of least burdensome 

11 concepts to premarket review and the applica12 tion of postmarket requirements to facilitate 

13 premarket decisionmaking; 

14 ‘‘(C) include in such audit an assessment 

15 of the measurement tools the Secretary uses to 

16 assess the implementation of the least burden17 some requirements, including the effectiveness 

18 of such tools and the effectiveness of the imple19 mentation of the least burdensome require20 ments; and 

21 ‘‘(D) within 30 calendar days of comple22 tion of the audit, make such audit available— 

23 ‘‘(i) to the Committee on Health, 

24 Education, Labor, and Pensions of the 

25 Senate and the Committee on Energy and 


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1 Commerce of the House of Representa2 tives; and 

3 ‘‘(ii) on the Internet website of the 

4 Food and Drug Administration.’’. 

5 (b) PREMARKET APPLICATIONS.—Section 515(c) of 

6 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 360e(c)) is amended by adding at the end the following: 

8 ‘‘(5)(A) In requesting additional information with re9 spect to an application under this section, the Secretary 

10 shall consider the least burdensome appropriate means 

11 necessary to demonstrate a reasonable assurance of device 

12 safety and effectiveness. 

13 ‘‘(B) For purposes of subparagraph (A) the term 

14 ‘necessary’ means the minimum required information that 

15 would support a determination by the Secretary that an 

16 application provides a reasonable assurance of the safety 

17 and effectiveness of the device. 

18 ‘‘(C) Nothing in this paragraph alters the standards 

19 for premarket approval of a device. 

20 ‘‘(D) For purposes of this paragraph, the Secretary 

21 shall consider whether the least burdensome means of 

22 demonstrating a reasonable assurance of device safety and 

23 effectiveness would be achieved through reliance on 

24 postmarket information.’’. 


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1 (c) RATIONALE FOR SIGNIFICANT DECISIONS RE2 GARDING DEVICES.—Section 517A(a) of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)) is 

4 amended by adding at the end the following: 

5 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE6 QUIREMENTS.—The substantive summary required 

7 under this subsection shall include an explanation of 

8 how the least burdensome requirements were consid9 ered and applied consistent with section 

10 513(i)(1)(D) and section 513(a)(3)(D) and section 

11 515(c)(5), as applicable.’’. 

12 SEC. 3. PERMITTING NON-LOCAL INSTITUTIONAL REVIEW 

13 BOARDS. 

14 (a) IN GENERAL.—Section 520 of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended— 

16 (1) in subsection (g)(3)— 

17 (A) by striking ‘‘local’’ each place it ap18 pears; and 

19 (B) in subparagraph (A)(i), by striking 

20 ‘‘which has been’’; and 

21 (2) in subsection (m)(4)— 

22 (A) by striking ‘‘local’’ each place it ap23 pears; and 

24 (B) by amending subparagraph (A) to read 

25 as follows: 


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1 ‘‘(A) in facilities in which clinical testing of de2 vices is supervised by an institutional review com3 mittee established in accordance with the regulations 

4 of the Secretary; and’’. 

5 (b) REGULATIONS.—Not later than 1 year after the 

6 date of the enactment of this Act, the Secretary of Health 

7 and Human Services shall revise or issue such regulations 

8 or guidance as may be necessary to carry out the amend9 ments made by subsection (a). 

10 SEC. 4. CLARIFYING CLIA WAIVER STUDY DESIGN GUID11 ANCE FOR IN VITRO DIAGNOSTICS. 

12 (a) DRAFT REVISED GUIDANCE.—Not later than 1 

13 year after the date of the enactment of this Act, the Sec14 retary of Health and Human Services shall publish a draft 

15 guidance that— 

16 (1) revises section ‘‘V. Demonstrating Insignifi17 cant Risk of an Erroneous Result’’ – ‘‘Accuracy’’ of 

18 the guidance entitled ‘‘Recommendations for Clinical 

19 Laboratory Improvement Amendments of 1988 

20 (CLIA) Waiver Applications for Manufacturers of In 

21 Vitro Diagnostic Devices’’ and dated January 30, 

22 2008; and 

23 (2) includes guidance on the appropriate use of 

24 comparable performance between a waived user and 


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1 a moderately complex laboratory user to dem2 onstrate accuracy. 

3 (b) FINAL REVISED GUIDANCE.—The Secretary of 

4 Health and Human Services shall finalize the draft guid5 ance published under subsection (a) not later than 1 year 

6 after the comment period for such draft guidance closes. 

7 SECTION 1. SHORT TITLE. 

8 This Act may be cited as the ‘‘FDA Device Account9 ability Act of 2016’’. 

10 SEC. 2. USE OF NONLOCAL INSTITUTIONAL REVIEW 

11 BOARDS FOR REVIEW OF INVESTIGATIONAL 

12 DEVICE EXEMPTIONS AND HUMAN DEVICE 

13 EXEMPTIONS. 

14 Section 520 of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 360j) is amended— 

16 (1) in subsection (g)(3)— 

17 (A) in subparagraph (A)(i)— 

18 (i) by striking ‘‘local’’; and 

19 (ii) by striking ‘‘which has been’’; and 

20 (B) in subparagraph (B), by striking ‘‘a 

21 local institutional’’ and inserting ‘‘an institu22 tional’’; and 

23 (2) in subsection (m)(4)— 

24 (A) by striking subparagraph (A) and in25 serting the following new subparagraph: 


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1 ‘‘(A) in facilities in which clinical testing of 

2 devices is supervised by an institutional review 

3 committee established in accordance with the reg4 ulations of the Secretary, and’’; 

5 (B) in subparagraph (B), by striking ‘‘a 

6 local institutional’’ and inserting ‘‘an institu7 tional’’; and 

8 (C) in the matter following subparagraph 

9 (B), by striking ‘‘local’’. 

10 SEC. 3. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN 

11 VITRO DIAGNOSTICS. 

12 (a) DRAFT REVISED GUIDANCE.—Not later than 1 

13 year after the date of the enactment of this Act, the Sec14 retary of Health and Human Services, acting through the 

15 Commissioner of Food and Drugs, shall publish a draft 

16 guidance that— 

17 (1) revises section ‘‘V. Demonstrating Insignifi18 cant Risk of an Erroneous Result’’ – ‘‘Accuracy’’ of 

19 the guidance entitled ‘‘Recommendations for Clinical 

20 Laboratory Improvement Amendments of 1988 

21 (CLIA) Waiver Applications for Manufacturers of In 

22 Vitro Diagnostic Devices’’ and dated January 30, 

23 2008; and 


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1 (2) includes the appropriate use of comparable 

2 performance between a waived user and a moderately 

3 complex laboratory user to demonstrate accuracy. 

4 (b) FINAL REVISED GUIDANCE.—The Secretary of 

5 Health and Human Services, acting through the Commis6 sioner of Food and Drugs, shall finalize the draft guidance 

7 published under subsection (a) not later than 1 year after 

8 the comment period for such draft guidance closes. 

9 SEC. 4. ENSURING LEAST BURDENSOME MEANS OF EVALU10 ATING DEVICES. 

11 (a) TRAINING AND OVERSIGHT OF LEAST BURDEN12 SOME REQUIREMENTS.—Section 513 of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 

14 adding at the end the following: 

15 ‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDEN16 SOME REQUIREMENTS.— 

17 ‘‘(1) TRAINING AND ASSESSMENT.—The Sec18 retary shall— 

19 ‘‘(A) ensure that each employee of the Food 

20 and Drug Administration who is involved in the 

21 review of premarket submissions, including su22 pervisors, receives training regarding the mean23 ing and implementation of the least burdensome 

24 requirements under subsections (a)(3)(D) and 

25 (i)(1)(D) and section 515(c)(5); and 


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1 ‘‘(B) periodically assess the implementation 

2 of the least burdensome requirements, including 

3 the employee training under subparagraph (A) 

4 to ensure that the least burdensome requirements 

5 are fully and consistently applied. 

6 ‘‘(2) OMBUDSMAN AUDIT.—Not later than 18 

7 months after the date of enactment of the FDA Device 

8 Accountability Act of 2016, the ombudsman for any 

9 organizational unit of the Food and Drug Adminis10 tration responsible for the premarket review of devices 

11 shall— 

12 ‘‘(A) conduct an audit of the training de13 scribed in paragraph (1)(A), including the effec14 tiveness of such training in implementing the 

15 least burdensome requirements; 

16 ‘‘(B) include in such audit interviews of 

17 persons who are representatives of the device in18 dustry regarding their experience in the device 

19 premarket review process, including with respect 

20 to the application of least burdensome concepts 

21 to premarket review and decisionmaking; 

22 ‘‘(C) include in such audit a list of the 

23 measurement tools the Secretary uses to assess 

24 the implementation of the least burdensome re25 quirements, including those referenced in paraVerDate Sep 11 2014 22:05 Apr 18, 2016 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\S1622.RS S1622

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1 graph (1)(B) and section 517A(a)(3), and may 

2 also provide feedback on the effectiveness of such 

3 tools in the implementation of the least burden4 some requirements; 

5 ‘‘(D) summarize the findings of such audit 

6 in a final audit report; and 

7 ‘‘(E) within 30 calendar days of completion 

8 of such final audit report, make such final audit 

9 report available— 

10 ‘‘(i) to the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate 

12 and the Committee on Energy and Com13 merce of the House of Representatives; and 

14 ‘‘(ii) on the Internet website of the 

15 Food and Drug Administration.’’. 

16 (b) PREMARKET APPLICATIONS.—Section 515(c) of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 

18 is amended by adding at the end the following: 

19 ‘‘(5)(A) In requesting additional information 

20 with respect to an application under this section, the 

21 Secretary shall consider the least burdensome appro22 priate means necessary to demonstrate a reasonable 

23 assurance of device safety and effectiveness. 

24 ‘‘(B) For purposes of subparagraph (A), the 

25 term ‘necessary’ means the minimum required 


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1 information that would support a determination 

2 by the Secretary that an application provides a 

3 reasonable assurance of the safety and effective4 ness of the device. 

5 ‘‘(C) For purposes of this paragraph, the 

6 Secretary shall consider the role of postmarket 

7 information in determining the least burdensome 

8 means of demonstrating a reasonable assurance 

9 of device safety and effectiveness. 

10 ‘‘(D) Nothing in this paragraph may alter 

11 the standards for premarket approval of a de12 vice.’’. 

13 (c) RATIONALE FOR SIGNIFICANT DECISIONS REGARD14 ING DEVICES.—Section 517A(a) of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 360g–1(a)) is amended by 

16 adding at the end the following: 

17 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE18 QUIREMENTS.—The substantive summary required 

19 under this subsection shall include a brief statement 

20 regarding how the least burdensome requirements 

21 were considered and applied consistent with section 

22 513(i)(1)(D), section 513(a)(3)(D), and section 

23 515(c)(5), as applicable.’’. 


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Calendar No. 426 

114TH CONGRESS 

2D SESSION S. 1622 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

Act with respect to devices. 

APRIL 18, 2016 

Reported with an amendment 


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