114 HR 5404 IH: Medical Device Guardians Act of 2016 U.S. House of Representatives 2016-06-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 114th CONGRESS 2d Session H. R. 5404 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.

1.

Short title

This Act may be cited as the Medical Device Guardians Act of 2016.

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.