Diagnostic Device Advisory Committee Act
Bill: H.R.7192 | Sponsor: Rep. Schrier, Kim (D-WA)
Policy area: Health

Summary:
Diagnostic Device Advisory Committee Act
This bill establishes the Real World Impact of Medical Devices Panel to advise the Food and Drug Administration on the real world impact of regulatory decisions relating to medical devices, including diagnostic devices.

To provide for the establishment of a panel on the real world impact of 
          diagnostic medical devices, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Diagnostic Device Advisory Committee 
Act''.

SEC. 2. REAL WORLD IMPACT OF MEDICAL DEVICES PANEL.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall, without regard to 
the provisions of title 5, United States Code, governing appointments 
in the competitive service, and without regard to the provisions of 
chapter 51 and subchapter III of chapter 53 of such title relating to 
classification and General Schedule pay rates, amend the charter of the 
Medical Devices Advisory Committee (or successor advisory committee) to 
establish a panel of experts on diagnostic medical device products for 
the purpose of providing advice to the Secretary in connection with the 
real world impact of the clearance, classification, approval, and 
authorization of devices, including diagnostic devices, under sections 
510(k), 513(f), 515, and 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(k), 360c(f), 360e, and 360bbb-3) to be known as the 
Real World Impact of Medical Devices Panel (referred to in this section 
as the ``Panel'').
    (b) Application of FACA.--The Federal Advisory Committee Act shall 
apply to the Panel.
    (c) Membership.--
            (1) In general.--The Panel shall consist of 15 members, 
        including the Chair.
            (2) Representation.--11 members of the Panel shall be 
        voting members. Of the remaining 4 members of the Panel--
                    (A) 1 shall be a representative of consumer 
                interests;
                    (B) 1 shall be a representative of the interests of 
                the device manufacturing industry; and
                    (C) 2 shall be public health or population health-
                specific representatives.
            (3) Term.--The members of the Panel specified in 
        subparagraphs (A) through (C) of paragraph (2) shall be 
        selected by the Secretary and shall be invited to serve for 
        rotating terms of such duration as specified by the Secretary, 
        except that any member appointed to fill a vacancy for an 
        unexpired term shall be appointed for the remainder of that 
        term.
    (d) Duties.--The Panel shall provide to the Secretary--
            (1) advice and recommendations on the real world impact of 
        the clearance, classification, approval, and authorization of 
        devices, including diagnostic devices, under sections 510(k), 
        513(f), 515, and 564 of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360(k), 360c(f), 360e, and 360bbb-3), including 
        the impact of such devices on rural, underserved, or minority 
        populations; and
            (2) register comments about the negative and positive 
        impacts of such devices on the United States population, the 
        risk assessment posed by the use of such devices, and the need 
        such devices would fill.
    (e) Consideration of Recommendations.--The Secretary, acting 
through the Commissioner of Food and Drugs, and any other applicable 
official shall, in making any final decisions, or amending existing 
decisions with respect to the clearance, classification, approval, and 
authorization of devices, including diagnostic devices, under sections 
510(k), 513(f), 515, and 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(k), 360c(f), 360e, and 360bbb-3), take comments 
received from the Panel under advisement.
    (f) Meetings.--
            (1) Frequency.--The Panel shall hold at least 1 meeting 
        each year, at the call of the Chair.
            (2) Recordings available.--Recordings of the meetings of 
        the Panel shall be available on the public website of the Food 
        and Drug Administration.
                                 <all>