Medical Device Guardians Act

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Device Guard- 4 ians Act’’. 5 VerDate Sep 11 2014 05:55 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2915.IH H2915 kjohnson on DSK79L0C42 with BILLS 2 •HR 2915 IH SEC. 2. REPORTING BY PHYSICIANS AND PHYSICIAN’S OF- 1 FICES ON CERTAIN ADVERSE EVENTS IN- 2 VOLVING MEDICAL DEVICES. 3 (a) EXTENDING REQUIREMENTS TO APPLY TO PHY- 4 SICIANS AND PHYSICIAN’S OFFICES.—Subparagraph (A) 5 of section 519(b)(6) of the Federal Food, Drug, and Cos- 6 metic Act (21 U.S.C. 360i(b)(6)) is amended to read as 7 follows: 8 ‘‘(A) The term ‘covered device user’ means a 9 hospital, ambulatory surgical facility, nursing home, 10 outpatient treatment facility, physician, or physi- 11 cian’s office. The Secretary may by regulation in- 12 clude an outpatient diagnostic facility.’’. 13 (b) CONFORMING AMENDMENTS.—Section 519 of the 14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) 15 is amended— 16 (1) in subsection (b)— 17 (A) by striking ‘‘device user facility’’ each 18 place it appears and inserting ‘‘covered device 19 user’’; 20 (B) by striking ‘‘the facility’’ each place it 21 appears and inserting ‘‘the user’’, except in the 22 phrase ‘‘the facility, individual, or physician’’ in 23 the matter following subparagraph (C) in para- 24 graph (3); 25 VerDate Sep 11 2014 05:55 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2915.IH H2915 kjohnson on DSK79L0C42 with BILLS 3 •HR 2915 IH (C) in paragraph (1)(D), by striking ‘‘that 1 facility’’ and inserting ‘‘that user’’; 2 (D) in paragraph (3)(B), by striking ‘‘such 3 a facility’’ and inserting ‘‘such a user’’; and 4 (E) in paragraph (5)— 5 (i) by striking ‘‘device user facilities’’ 6 and inserting ‘‘covered device users’’; 7 (ii) by striking ‘‘of user facilities’’ and 8 inserting ‘‘of users’’; and 9 (iii) by striking ‘‘a user facility’’ and 10 inserting ‘‘a user’’; 11 (2) in subsection (b)(3)— 12 (A) in subparagraph (A), by adding ‘‘or’’ 13 at the end; 14 (B) in subparagraph (B), by striking ‘‘or’’ 15 at the end; and 16 (C) by striking subparagraph (C); and 17 (3) in subsection (e)(1)(B)(ii), by striking ‘‘out- 18 side a device user facility’’ and inserting ‘‘by a per- 19 son other than a covered device user (as defined in 20 subsection (b))’’. 21 (c) APPLICABILITY.—The amendments made by this 22 section apply beginning on the date that is 3 years after 23 the date of enactment of this Act. 24 VerDate Sep 11 2014 05:55 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2915.IH H2915 kjohnson on DSK79L0C42 with BILLS 4 •HR 2915 IH SEC. 3. ELECTRONIC SYSTEM TO FACILITATE REPORTING 1 BY COVERED DEVICE USERS. 2 (a) IN GENERAL.—Section 519(b) of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 360i(b)), as 4 amended by section 2, is further amended— 5 (1) by redesignating paragraph (6) as para- 6 graph (7); and 7 (2) by inserting after paragraph (5) the fol- 8 lowing new paragraph: 9 ‘‘(6) The Secretary shall establish and operate 10 an electronic reporting system to facilitate compli- 11 ance with this subsection by covered device users 12 who choose to use such system to submit reports 13 pursuant to this subsection.’’. 14 (b) COMMENCEMENT.—Not later than 3 years after 15 the date of enactment of this Act, the Secretary of Health 16 and Human Services, acting through the Commissioner of 17 Food and Drugs, shall commence operation of the elec- 18 tronic reporting system required by section 519(b)(6) of 19 the Federal Food, Drug, and Cosmetic Act, as added by 20 subsection (a). 21 SEC. 4. PUBLIC AVAILABILITY OF REPORTS. 22 Section 519 of the Federal Food, Drug, and Cosmetic 23 Act (21 U.S.C. 360i) is amended by adding at the end 24 the following new subsection: 25 ‘‘(j) PUBLIC AVAILABILITY OF REPORTS.— 26 VerDate Sep 11 2014 05:55 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2915.IH H2915 kjohnson on DSK79L0C42 with BILLS 5 •HR 2915 IH ‘‘(1) IN GENERAL.—Notwithstanding any ex- 1 emption for withholding information under section 2 552 of title 5, United States Code, but subject to 3 paragraph (2), the Secretary shall make reports sub- 4 mitted under this section publicly available on the 5 website of the Department of Health and Human 6 Services. 7 ‘‘(2) INDIVIDUALLY IDENTIFIABLE PATIENT IN- 8 FORMATION.—Paragraph (1) does not require the 9 Secretary to make publicly available any individually 10 identifiable patient information.’’. 11 Æ VerDate Sep 11 2014 05:55 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H2915.IH H2915 kjohnson on DSK79L0C42 with BILLS