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

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel.

The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to the device and at least one member who is knowledgeable about the technology of the device.

The person whose device is under review may designate a representative (who may be accompanied by experts) to participate in panel meetings.

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2427 Introduced in House (IH)]

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.

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

SECTION 1. ADVISORY COMMITTEE PROCESS.

    (a) Classification Panels.--Paragraph (5) of section 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
            (1) by striking ``(5)'' and inserting ``(5)(A)''; and
            (2) by adding at the end the following:
                    ``(B) For review by a classification panel of a 
                premarket submission for a device, the Secretary 
                shall--
                            ``(i) provide an opportunity for the person 
                        whose premarket submission is subject to panel 
                        review to provide recommendations on the 
                        expertise needed among the voting members of 
                        the panel; and
                            ``(ii) give due consideration to such 
                        recommendations and ensure that adequate 
                        expertise is represented on advisory panels to 
                        assess--
                                    ``(I) the disease or condition for 
                                which the device is intended to cure, 
                                treat, mitigate, prevent, or diagnose; 
                                and
                                    ``(II) the technology of the 
                                device.
                    ``(C) For purposes of subparagraph (B)(ii), the 
                term `adequate expertise' means that the membership of 
                the classification panel reviewing a premarket 
                submission includes--
                            ``(i) two or more voting members, with a 
                        specialty or other expertise clinically 
                        relevant to the device under review; and
                            ``(ii) at least one voting member who is 
                        knowledgeable about the technology of the 
                        device.''.
    (b) Panel Review Process.--Section 513(b)(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
            (1) in subparagraph (A)(iii), by inserting before the 
        period at the end ``, including by designating a representative 
        who will be provided a time during the panel meeting to address 
        the panel individually (or accompanied by experts selected by 
        such representative) for the purpose of correcting 
        misstatements of fact or providing clarifying information, 
        subject to the discretion of panel chairperson.''.
            (2) by striking subparagraph (B) and inserting the 
        following new subparagraph:
                    ``(B)(i) Any meeting of a classification panel with 
                respect to the review of a premarket submission for a 
                device shall--
                            ``(I) provide adequate time for initial 
                        presentations by the person whose premarket 
                        submission is specifically the subject of such 
                        review and by the Secretary; and
                            ``(II) encourage free and open 
                        participation by all interested persons.
                    ``(ii) Following the initial presentations 
                described in clause (i), the panel may--
                            ``(I) pose questions to a designated 
                        representative described in subparagraph 
                        (A)(iii); and
                            ``(II) consider the responses to such 
                        questions in the panel's review of the 
                        premarket submission.''.
                                 <all>