I 
117TH CONGRESS 
2D SESSION 
H. R. 7192 
To provide for the establishment of a panel on the real world impact of 
diagnostic medical devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 21, 2022 
Ms. SCHRIER introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Diagnostic Device Ad-
visory 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 ‘‘Sec-
retary’’) shall, without regard to the provisions of title 5, 
United States Code, governing appointments in the com-
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petitive 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 Com-
mittee (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 connec-
tion with the real world impact of the clearance, classifica-
tion, approval, and authorization of devices, including di-
agnostic 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 (re-
ferred 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; 
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(B) 1 shall be a representative of the inter-
ests of the device manufacturing industry; and 
(C) 2 shall be public health or population 
health-specific representatives. 
(3) TERM.—The members of the Panel speci-
fied 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 mem-
ber 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 Sec-
retary— 
(1) advice and recommendations on the real 
world impact of the clearance, classification, ap-
proval, and authorization of devices, including diag-
nostic 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 
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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 au-
thorization 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. 
Æ 
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