I 116th CONGRESS 1st Session H. R. 2915 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. Short title This Act may be cited as the Medical Device Guardians Act . 2. Reporting by physicians and physician’s offices on certain adverse events involving medical devices (a) Extending requirements To apply to physicians and physician’s offices Subparagraph (A) of section 519(b)(6) of the Federal Food, Drug, and Cosmetic 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 physician's office. The Secretary may by regulation include 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 paragraph (3); (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 outside a device user facility and inserting by a person 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. 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 paragraph (7); and (2) by inserting after paragraph (5) the following new paragraph: (6) The Secretary shall establish and operate an electronic reporting system to facilitate compliance 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 electronic reporting system required by section 519(b)(6) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). 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 (1) In general Notwithstanding any exemption for withholding information under section 552 of title 5, United States Code, but subject to paragraph (2), the Secretary shall make reports submitted under this section publicly available on the website of the Department of Health and Human Services. (2) Individually identifiable patient information Paragraph (1) does not require the Secretary to make publicly available any individually identifiable patient information. .