```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5404 Introduced in House (IH)]

<DOC>

114th CONGRESS
  2d Session
                                H. R. 5404

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

                              June 8, 2016

Mr. Fitzpatrick (for himself, Ms. Slaughter, and Mr. Zinke) 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 of 
2016''.

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.
                                 <all>
```