The Medical Device Guardians Act
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H.R. 2915 Medical Device Guardians Act of 2019
I am asking for your support of The Medical Device Guardians Act H.R. 2915. This bill will REQUIRE physicians to file an adverse event report with the FDA when they see a patient that has or had an adverse event from a medical device.
Currently, this is NOT a requirement! Requiring this action will help to ensure that the FDA quickly flags devices that are causing injury or death.
Adverse event reports are the FDAs way of hearing about prescription drug and medical device problems in the real world. Once a device is approved, the FDA can receive reports from consumers, physicians, hospitals, or manufacturers. Currently only the latter two are required to file reports. Including physicians in on this requirement would help the FDA track safety and efficacy of devices. Most patients go to their doctor when they are experiencing a problem, therefore a report of that problem would give real time alerts to the FDA. Often patients don’t even know what an adverse event report is, let alone know how to file one.
Adverse event reporting can be done on the FDAs website.
The Medical Device Guardians Act was sponsored by:
Rep. Fitzpatrick, Brian K. [R-PA-1] (Introduced 05/22/2019)
House - Energy and Commerce
Rep. Doggett, Lloyd [D-TX-35]*
Rep. DeLauro, Rosa L. [D-CT-3]*
Rep. Schakowsky, Janice D. [D-IL-9]*
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 Representatives of the United States of America in Congress assembled,
SECTION 1. Short title.
This Act may be cited as the “Medical Device Guardians Act of 2019”.
SEC. 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 user”;
(ii) by striking “of user facilities” and inserting “of users”;
(iii) by striking “a user facility” and inserting “a user”; and
(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;
(C) by striking subparagraph (C); and
(3) in subsection (e)(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.