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.
Short title
This Act may be cited as the Medical Device Integrity Act
.
Records and other information inspection
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—
in the first sentence, by inserting or device
after processing of a drug
; and
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 sufficient description of the records requested; and
a rationale for requesting such information in advance of, or in lieu of, an inspection.
.
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Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance describing the circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection,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 The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.