I 
116TH CONGRESS 
1ST SESSION H. R. 2915 
To amend the Federal Food, Drug, and Cosmetic Act to require physicians 
and physician’s offices to be treated as covered device users required 
to report on certain adverse events involving medical devices, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 22, 2019 
Mr. FITZPATRICK (for himself, Mr. DOGGETT, Ms. DELAURO, and Ms. SCHA-
KOWSKY) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
require physicians and physician’s offices to be treated 
as covered device users required to report on certain 
adverse events involving 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 ‘‘Medical Device Guard-
ians Act’’. 
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SEC. 2. REPORTING BY PHYSICIANS AND PHYSICIAN’S OF-
FICES ON CERTAIN ADVERSE EVENTS IN-
VOLVING MEDICAL DEVICES. 
(a) EXTENDING REQUIREMENTS TO APPLY TO PHY-
SICIANS AND PHYSICIAN’S OFFICES.—Subparagraph (A) 
of section 519(b)(6) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360i(b)(6)) is amended to read as 
follows: 
‘‘(A) The term ‘covered device user’ means a 
hospital, ambulatory surgical facility, nursing home, 
outpatient treatment facility, physician, or physi-
cian’s office. The Secretary may by regulation in-
clude an outpatient diagnostic facility.’’. 
(b) CONFORMING AMENDMENTS.—Section 519 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) 
is amended— 
(1) in subsection (b)— 
(A) by striking ‘‘device user facility’’ each 
place it appears and inserting ‘‘covered device 
user’’; 
(B) by striking ‘‘the facility’’ each place it 
appears and inserting ‘‘the user’’, except in the 
phrase ‘‘the facility, individual, or physician’’ in 
the matter following subparagraph (C) in para-
graph (3); 
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(C) in paragraph (1)(D), by striking ‘‘that 
facility’’ and inserting ‘‘that user’’; 
(D) in paragraph (3)(B), by striking ‘‘such 
a facility’’ and inserting ‘‘such a user’’; and 
(E) in paragraph (5)— 
(i) by striking ‘‘device user facilities’’ 
and inserting ‘‘covered device users’’; 
(ii) by striking ‘‘of user facilities’’ and 
inserting ‘‘of users’’; and 
(iii) by striking ‘‘a user facility’’ and 
inserting ‘‘a user’’; 
(2) in subsection (b)(3)— 
(A) in subparagraph (A), by adding ‘‘or’’ 
at the end; 
(B) in subparagraph (B), by striking ‘‘or’’ 
at the end; and 
(C) by striking subparagraph (C); and 
(3) in subsection (e)(1)(B)(ii), by striking ‘‘out-
side a device user facility’’ and inserting ‘‘by a per-
son other than a covered device user (as defined in 
subsection (b))’’. 
(c) APPLICABILITY.—The amendments made by this 
section apply beginning on the date that is 3 years after 
the date of enactment of this Act. 
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SEC. 3. ELECTRONIC SYSTEM TO FACILITATE REPORTING 
BY COVERED DEVICE USERS. 
(a) IN GENERAL.—Section 519(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i(b)), as 
amended by section 2, is further amended— 
(1) by redesignating paragraph (6) as para-
graph (7); and 
(2) by inserting after paragraph (5) the fol-
lowing new paragraph: 
‘‘(6) The Secretary shall establish and operate 
an electronic reporting system to facilitate compli-
ance with this subsection by covered device users 
who choose to use such system to submit reports 
pursuant to this subsection.’’. 
(b) COMMENCEMENT.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall commence operation of the elec-
tronic reporting system required by section 519(b)(6) of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a). 
SEC. 4. PUBLIC AVAILABILITY OF REPORTS. 
Section 519 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i) is amended by adding at the end 
the following new subsection: 
‘‘(j) PUBLIC AVAILABILITY OF REPORTS.— 
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‘‘(1) IN
GENERAL.—Notwithstanding any ex-
emption for withholding information under section 
552 of title 5, United States Code, but subject to 
paragraph (2), the Secretary shall make reports sub-
mitted under this section publicly available on the 
website of the Department of Health and Human 
Services. 
‘‘(2) INDIVIDUALLY IDENTIFIABLE PATIENT IN-
FORMATION.—Paragraph (1) does not require the 
Secretary to make publicly available any individually 
identifiable patient information.’’. 
Æ 
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