Medical Device Guardians Act

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) (A) The term covered device user . (b) Conforming amendments Section 519 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360i (1) in subsection (b)— (A) by striking device user facility covered device user (B) by striking the facility the user the facility, individual, or physician (C) in paragraph (1)(D), by striking that facility that user (D) in paragraph (3)(B), by striking such a facility such a user (E) in paragraph (5)— (i) by striking device user facilities covered device users (ii) by striking of user facilities of users (iii) by striking a user facility a user (2) in subsection (b)(3)— (A) in subparagraph (A), by adding or (B) in subparagraph (B), by striking or (C) by striking subparagraph (C); and (3) in subsection (e)(1)(B)(ii), by striking outside a device user facility 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) (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 (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. .

Summary: Medical Device Guardians Act This bill requires physicians to report significant adverse experiences caused by medical devices to the Food and Drug Administration (FDA). The FDA must establish an electronic reporting system to facilitate compliance with this bill and must publish the reports online.