Medical Device Guardians Act

Bill: 115-hr-2163
Sponsor: full_name: Rep. Fitzpatrick, Brian K. [R-PA-8]
Introduced: 2017-04-26
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Health care quality

Health information and medical records

Health personnel

Health technology, devices, supplies

Product safety and quality
Latest action: action_date: 2017-05-05
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2017-04-26
action_desc: Introduced in House
text: <p><b>Medical Device Guardians Act</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require physicians to report significant adverse experiences caused by medical devices to the Food and Drug Administration.</p>

tv_txt: I 115th CONGRESS 1st Session H. R. 2163 IN THE HOUSE OF REPRESENTATIVES April 26, 2017 Mr. Fitzpatrick (for himself, Ms. Slaughter , and Ms. DeLauro ) 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 . 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 ; 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.