I 

114TH CONGRESS 

1ST SESSION H. R. 2427 

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

committee process. 

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 advisory committee process. 

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

3 SECTION 1. ADVISORY COMMITTEE PROCESS. 

4 (a) CLASSIFICATION PANELS.—Paragraph (5) of sec5 tion 513(b) of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 360c(b)) is amended— 

7 (1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 

8 and 

9 (2) by adding at the end the following: 


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1 ‘‘(B) For review by a classification panel of 

2 a premarket submission for a device, the Sec3 retary shall— 

4 ‘‘(i) provide an opportunity for the 

5 person whose premarket submission is sub6 ject to panel review to provide rec7 ommendations on the expertise needed 

8 among the voting members of the panel; 

9 and 

10 ‘‘(ii) give due consideration to such 

11 recommendations and ensure that adequate 

12 expertise is represented on advisory panels 

13 to assess— 

14 ‘‘(I) the disease or condition for 

15 which the device is intended to cure, 

16 treat, mitigate, prevent, or diagnose; 

17 and 

18 ‘‘(II) the technology of the de19 vice. 

20 ‘‘(C) For purposes of subparagraph (B)(ii), 

21 the term ‘adequate expertise’ means that the 

22 membership of the classification panel reviewing 

23 a premarket submission includes— 


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1 ‘‘(i) two or more voting members, with 

2 a specialty or other expertise clinically rel3 evant to the device under review; and 

4 ‘‘(ii) at least one voting member who 

5 is knowledgeable about the technology of 

6 the device.’’. 

7 (b) PANEL REVIEW PROCESS.—Section 513(b)(6) of 

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

9 360c(b)(6)) is amended— 

10 (1) in subparagraph (A)(iii), by inserting before 

11 the period at the end ‘‘, including by designating a 

12 representative who will be provided a time during 

13 the panel meeting to address the panel individually 

14 (or accompanied by experts selected by such rep15 resentative) for the purpose of correcting 

16 misstatements of fact or providing clarifying infor17 mation, subject to the discretion of panel chair18 person.’’. 

19 (2) by striking subparagraph (B) and inserting 

20 the following new subparagraph: 

21 ‘‘(B)(i) Any meeting of a classification 

22 panel with respect to the review of a premarket 

23 submission for a device shall— 

24 ‘‘(I) provide adequate time for initial 

25 presentations by the person whose preVerDate Sep 11 2014 02:19 May 27, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2427.IH H2427

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1 market submission is specifically the sub2 ject of such review and by the Secretary; 

3 and 

4 ‘‘(II) encourage free and open partici5 pation by all interested persons. 

6 ‘‘(ii) Following the initial presentations de7 scribed in clause (i), the panel may— 

8 ‘‘(I) pose questions to a designated 

9 representative described in subparagraph 

10 (A)(iii); and 

11 ‘‘(II) consider the responses to such 

12 questions in the panel’s review of the pre13 market submission.’’. 

Æ 


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