I 
114TH CONGRESS 
2D SESSION 
H. R. 5404 
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 
JUNE 8, 2016 
Mr. FITZPATRICK (for himself, Ms. SLAUGHTER, and Mr. ZINKE) 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 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 of 2016’’. 
VerDate Sep 11 2014 
03:25 Jun 09, 2016
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5404.IH
H5404
rfrederick on DSK6VPTVN1PROD with BILLS
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); 
VerDate Sep 11 2014 
03:25 Jun 09, 2016
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5404.IH
H5404
rfrederick on DSK6VPTVN1PROD with BILLS
(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 user’’; 
(ii) by striking ‘‘of user facilities’’ and 
inserting ‘‘of users’’; 
(iii) by striking ‘‘a user facility’’ and 
inserting ‘‘a user’’; and 
(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; 
(C) by striking subparagraph (C); and 
(3) in subsection (e)(B)(ii), by striking ‘‘outside 
a device user facility’’ and inserting ‘‘by a person 
other than a covered device user (as defined in sub-
section (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. 
Æ 
VerDate Sep 11 2014 
03:25 Jun 09, 2016
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\H5404.IH
H5404
rfrederick on DSK6VPTVN1PROD with BILLS