II 

114TH CONGRESS 

1ST 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 and Mr. FRANKEN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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’’. 

6 SEC. 2. ENSURING LEAST BURDENSOME MEANS OF EVALU7 ATING DEVICES. 

8 (a) TRAINING AND OVERSIGHT OF LEAST BURDEN9 SOME REQUIREMENTS.—Section 513 of the Federal Food, 


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

2 adding at the end the following: 

3 ‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDEN4 SOME REQUIREMENTS.— 

5 ‘‘(1) TRAINING AND ASSESSMENT.—The Sec6 retary shall— 

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

8 Food and Drug Administration who is involved 

9 in the review of premarket submissions, includ10 ing supervisors, receives training regarding the 

11 meaning and implementation of the least bur12 densome requirements under subsections 

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

14 and 

15 ‘‘(B) periodically assess the implementa16 tion of the least burdensome requirements, in17 cluding the employee training under subpara18 graph (A) to ensure that the least burdensome 

19 requirements are fully and consistently applied. 

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

21 calendar days after the date of enactment of the 

22 FDA Device Accountability Act of 2015, the om23 budsman for any organizational unit of the Food 

24 and Drug Administration responsible for the pre25 market review of devices shall— 


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1 ‘‘(A) conduct an audit of the training de2 scribed in paragraph (1)(A); 

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

4 persons who are representatives of the device 

5 industry regarding their experience in the de6 vice premarket review process, including with 

7 respect to the application of least burdensome 

8 concepts to premarket review and the applica9 tion of postmarket requirements to facilitate 

10 premarket decisionmaking; 

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

12 of the measurement tools the Secretary uses to 

13 assess the implementation of the least burden14 some requirements, including the effectiveness 

15 of such tools and the effectiveness of the imple16 mentation of the least burdensome require17 ments; and 

18 ‘‘(D) within 30 calendar days of comple19 tion of the audit, make such audit available— 

20 ‘‘(i) to the Committee on Health, 

21 Education, Labor, and Pensions of the 

22 Senate and the Committee on Energy and 

23 Commerce of the House of Representa24 tives; and 


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

2 Food and Drug Administration.’’. 

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

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

5 360e(c)) is amended by adding at the end the following: 

6 ‘‘(5)(A) In requesting additional information with re7 spect to an application under this section, the Secretary 

8 shall consider the least burdensome appropriate means 

9 necessary to demonstrate a reasonable assurance of device 

10 safety and effectiveness. 

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

12 ‘necessary’ means the minimum required information that 

13 would support a determination by the Secretary that an 

14 application provides a reasonable assurance of the safety 

15 and effectiveness of the device. 

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

17 for premarket approval of a device. 

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

19 shall consider whether the least burdensome means of 

20 demonstrating a reasonable assurance of device safety and 

21 effectiveness would be achieved through reliance on 

22 postmarket information.’’. 

23 (c) RATIONALE FOR SIGNIFICANT DECISIONS RE24 GARDING DEVICES.—Section 517A(a) of the Federal 


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

2 amended by adding at the end the following: 

3 ‘‘(3) APPLICATION OF LEAST BURDENSOME RE4 QUIREMENTS.—The substantive summary required 

5 under this subsection shall include an explanation of 

6 how the least burdensome requirements were consid7 ered and applied consistent with section 

8 513(i)(1)(D) and section 513(a)(3)(D) and section 

9 515(c)(5), as applicable.’’. 

10 SEC. 3. PERMITTING NON-LOCAL INSTITUTIONAL REVIEW 

11 BOARDS. 

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

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

14 (1) in subsection (g)(3)— 

15 (A) by striking ‘‘local’’ each place it ap16 pears; and 

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

18 ‘‘which has been’’; and 

19 (2) in subsection (m)(4)— 

20 (A) by striking ‘‘local’’ each place it ap21 pears; and 

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

23 as follows: 

24 ‘‘(A) in facilities in which clinical testing of de25 vices is supervised by an institutional review comVerDate Sep 11 2014 03:02 Jun 23, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1622.IS S1622

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1 mittee established in accordance with the regulations 

2 of the Secretary; and’’. 

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

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

5 and Human Services shall revise or issue such regulations 

6 or guidance as may be necessary to carry out the amend7 ments made by subsection (a). 

8 SEC. 4. CLARIFYING CLIA WAIVER STUDY DESIGN GUID9 ANCE FOR IN VITRO DIAGNOSTICS. 

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

11 year after the date of the enactment of this Act, the Sec12 retary of Health and Human Services shall publish a draft 

13 guidance that— 

14 (1) revises section ‘‘V. Demonstrating Insignifi15 cant Risk of an Erroneous Result’’ – ‘‘Accuracy’’ of 

16 the guidance entitled ‘‘Recommendations for Clinical 

17 Laboratory Improvement Amendments of 1988 

18 (CLIA) Waiver Applications for Manufacturers of In 

19 Vitro Diagnostic Devices’’ and dated January 30, 

20 2008; and 

21 (2) includes guidance on the appropriate use of 

22 comparable performance between a waived user and 

23 a moderately complex laboratory user to dem24 onstrate accuracy. 


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

2 Health and Human Services shall finalize the draft guid3 ance published under subsection (a) not later than 1 year 

4 after the comment period for such draft guidance closes. 

Æ 


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