Medical Device Integrity Act

Bill: 117-s-3395
Sponsor: full_name: Sen. Baldwin, Tammy [D-WI]
Introduced: 2021-12-14
Policy area: Health
Latest action: action_date: 2021-12-14
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-12-14
action_desc: Introduced in Senate
text: <p><strong>Medical Device Integrity Act</strong></p> <p>This bill provides the Food and Drug Administration (FDA) with the authority to request records and information from an establishment that manufactures or otherwise prepares medical devices. Currently, the FDA only has statutory authority to make such requests to establishments that manufacture or otherwise prepare drugs. </p> <p>The bill also requires the FDA to include in its requests a rationale for requesting the information in question. </p>

tv_txt: II 117th CONGRESS 1st Session S. 3395 IN THE SENATE OF THE UNITED STATES December 14, 2021 Ms. Baldwin (for herself and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections.

1. Short title This Act may be cited as the Medical Device Integrity Act . 2. Records and other information inspection (a) In general Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(4)(A) ) is amended— (1) in the first sentence, by inserting or device after processing of a drug ; and (2) in the second sentence, by striking shall include and all that follows through the period at the end and inserting the following: “shall include— (A) a sufficient description of the records requested; and (B) a rationale for requesting such information in advance of, or in lieu of, an inspection. . (b) Guidance Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance describing the circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection, processes for responding to such requests electronically or in physical form, and factors the Secretary intends to consider in evaluating whether such records are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.