Section 1 Short title
This Act may be cited as the “Medical Device Guardians Act of 2016”.
Medical Device Guardians Act of 2016
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.
Sec. 2 Reporting by physicians and physician’s offices on certain adverse events involving medical devices
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.”
Conforming amendments— Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended—
in subsection (b)—
by striking “device user facility” each place it appears and inserting “covered device user”;
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);
in paragraph (1)(D), by striking “that facility” and inserting “that user”;
in paragraph (3)(B), by striking “such a facility” and inserting “such a user”; and
in paragraph (5)—
by striking “device user facilities” and inserting “covered device user”;
by striking “of user facilities” and inserting “of users”;
by striking “a user facility” and inserting “a user”; and
in subsection (b)(3)—
in subparagraph (A), by adding “or” at the end;
in subparagraph (B), by striking “or” at the end;
by striking subparagraph (C); and
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))”.
Applicability— The amendments made by this section apply beginning on the date that is 3 years after the date of enactment of this Act.