Title: Medical Device Guardians Act
Policy area: Health

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.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2915 Introduced in House (IH)]

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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.

    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''.

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 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.

SEC. 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).

SEC. 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.''.
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