117 S3395 IS: Medical Device Integrity Act U.S. Senate 2021-12-14 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.

II117th CONGRESS1st SessionS. 3395IN THE SENATE OF THE UNITED STATESDecember 14, 2021Ms. Baldwin (for herself and Mr. Cassidy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo 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Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance describing the circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection,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 The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.