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. SCHAKOWSKY) 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’’. 


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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 users’’; 

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

9 inserting ‘‘of users’’; and 

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

11 inserting ‘‘a user’’; 

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; and 

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

18 (3) in subsection (e)(1)(B)(ii), by striking ‘‘out19 side a device user facility’’ and inserting ‘‘by a per20 son other than a covered device user (as defined in 

21 subsection (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. 


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1 SEC. 3. ELECTRONIC SYSTEM TO FACILITATE REPORTING 

2 BY COVERED DEVICE USERS. 

3 (a) IN GENERAL.—Section 519(b) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 360i(b)), as 

5 amended by section 2, is further amended— 

6 (1) by redesignating paragraph (6) as para7 graph (7); and 

8 (2) by inserting after paragraph (5) the fol9 lowing new paragraph: 

10 ‘‘(6) The Secretary shall establish and operate 

11 an electronic reporting system to facilitate compli12 ance with this subsection by covered device users 

13 who choose to use such system to submit reports 

14 pursuant to this subsection.’’. 

15 (b) COMMENCEMENT.—Not later than 3 years after 

16 the date of enactment of this Act, the Secretary of Health 

17 and Human Services, acting through the Commissioner of 

18 Food and Drugs, shall commence operation of the elec19 tronic reporting system required by section 519(b)(6) of 

20 the Federal Food, Drug, and Cosmetic Act, as added by 

21 subsection (a). 

22 SEC. 4. PUBLIC AVAILABILITY OF REPORTS. 

23 Section 519 of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 360i) is amended by adding at the end 

25 the following new subsection: 

26 ‘‘(j) PUBLIC AVAILABILITY OF REPORTS.— 


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1 ‘‘(1) IN GENERAL.—Notwithstanding any ex2 emption for withholding information under section 

3 552 of title 5, United States Code, but subject to 

4 paragraph (2), the Secretary shall make reports sub5 mitted under this section publicly available on the 

6 website of the Department of Health and Human 

7 Services. 

8 ‘‘(2) INDIVIDUALLY IDENTIFIABLE PATIENT IN9 FORMATION.—Paragraph (1) does not require the 

10 Secretary to make publicly available any individually 

11 identifiable patient information.’’. 

Æ 


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