I 

114TH CONGRESS 

1ST SESSION H. R. 2424 

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

and oversight in least burdensome appropriate means concept. 

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 training and oversight in least burdensome 

appropriate means concept. 

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

3 SECTION 1. TRAINING AND OVERSIGHT IN LEAST BURDEN4 SOME APPROPRIATE MEANS CONCEPT. 

5 (a) IN GENERAL.—Section 513 of the Federal Food, 

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

7 inserting after subsection (i) the following: 

8 ‘‘(j) TRAINING AND OVERSIGHT IN LEAST BURDEN9 SOME APPROPRIATE MEANS CONCEPT.— 


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1 ‘‘(1) TRAINING.—Each employee of the Food 

2 and Drug Administration who is involved in the re3 view of premarket submissions under section 515 or 

4 section 510(k), including supervisors, shall receive 

5 training regarding the meaning and implementation 

6 of the least burdensome appropriate means concept 

7 in the context of the use of that term in subsections 

8 (a)(3)(D) and (i)(1)(D) of this section and in section 

9 515(c)(5). 

10 ‘‘(2) GUIDANCE DOCUMENTS.— 

11 ‘‘(A) DRAFT UPDATED GUIDANCE.—Not 

12 later than 12 months after the date of enact13 ment of the 21st Century Cures Act, the Sec14 retary shall issue a draft guidance document 

15 updating the October 4, 2002, guidance docu16 ment entitled ‘The Least Burdensome Provision 

17 of the FDA Modernization Act of 1997: Con18 cept and Principles; Final Guidance for FDA 

19 and Industry’. 

20 ‘‘(B) MEETING OF STAKEHOLDERS.—In 

21 developing such draft guidance document, the 

22 Secretary shall convene a meeting of stake23 holders to ensure a full record to support the 

24 publication of such document. 


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1 ‘‘(3) OMBUDSMAN AUDIT.—Not later than 18 

2 months after the date of issuance of final version of 

3 the draft guidance under paragraph (2), the om4 budsman for the organizational unit of the Food and 

5 Drug Administration responsible for the premarket 

6 review of devices shall— 

7 ‘‘(A) conduct, or have conducted, an audit 

8 of the training described in paragraph (1); and 

9 ‘‘(B) include in such audit interviews with 

10 a representative sample of persons from indus11 try regarding their experience in the device pre12 market review process.’’. 

13 (b) ADDITIONAL INFORMATION REGARDING PRE14 MARKET APPLICATIONS.—Subsection (c) of section 515 of 

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

16 360e) is amended by adding at the end the follows: 

17 ‘‘(5)(A) Whenever the Secretary requests additional 

18 information from an applicant regarding an application 

19 under paragraph (1), the Secretary shall consider the least 

20 burdensome appropriate means necessary to demonstrate 

21 device safety and effectiveness, and request information 

22 accordingly. 

23 ‘‘(B) For purposes of subparagraph (A), the term 

24 ‘necessary’ means the minimum required information that 

25 would support a determination by the Secretary that an 


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1 application provides a reasonable assurance of the safety 

2 and effectiveness of the device. 

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

4 for premarket approval of a device.’’. 

Æ 


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