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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Device Guard5 ians Act of 2016’’. 


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1 SEC. 2. REPORTING BY PHYSICIANS AND PHYSICIAN’S OF2 FICES ON CERTAIN ADVERSE EVENTS IN3 VOLVING MEDICAL DEVICES. 

4 (a) EXTENDING REQUIREMENTS TO APPLY TO PHY5 SICIANS AND PHYSICIAN’S OFFICES.—Subparagraph (A) 

6 of section 519(b)(6) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 360i(b)(6)) is amended to read as 

8 follows: 

9 ‘‘(A) The term ‘covered device user’ means a 

10 hospital, ambulatory surgical facility, nursing home, 

11 outpatient treatment facility, physician, or physi12 cian’s office. The Secretary may by regulation in13 clude an outpatient diagnostic facility.’’. 

14 (b) CONFORMING AMENDMENTS.—Section 519 of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) 

16 is amended— 

17 (1) in subsection (b)— 

18 (A) by striking ‘‘device user facility’’ each 

19 place it appears and inserting ‘‘covered device 

20 user’’; 

21 (B) by striking ‘‘the facility’’ each place it 

22 appears and inserting ‘‘the user’’, except in the 

23 phrase ‘‘the facility, individual, or physician’’ in 

24 the matter following subparagraph (C) in para25 graph (3); 


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1 (C) in paragraph (1)(D), by striking ‘‘that 

2 facility’’ and inserting ‘‘that user’’; 

3 (D) in paragraph (3)(B), by striking ‘‘such 

4 a facility’’ and inserting ‘‘such a user’’; and 

5 (E) in paragraph (5)— 

6 (i) by striking ‘‘device user facilities’’ 

7 and inserting ‘‘covered device user’’; 

8 (ii) by striking ‘‘of user facilities’’ and 

9 inserting ‘‘of users’’; 

10 (iii) by striking ‘‘a user facility’’ and 

11 inserting ‘‘a user’’; and 

12 (2) in subsection (b)(3)— 

13 (A) in subparagraph (A), by adding ‘‘or’’ 

14 at the end; 

15 (B) in subparagraph (B), by striking ‘‘or’’ 

16 at the end; 

17 (C) by striking subparagraph (C); and 

18 (3) in subsection (e)(B)(ii), by striking ‘‘outside 

19 a device user facility’’ and inserting ‘‘by a person 

20 other than a covered device user (as defined in sub21 section (b))’’. 

22 (c) APPLICABILITY.—The amendments made by this 

23 section apply beginning on the date that is 3 years after 

24 the date of enactment of this Act. 

Æ 


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