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Senate Bill 3395
117th Congress(2021-2022)
Medical Device Integrity Act
Introduced
Introduced
Introduced in Senate on Dec 14, 2021
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Introduced in Senate 
Dec 14, 2021
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Introduced in Senate(Dec 14, 2021)
Dec 14, 2021
No Linkage Found
About Linkage
Multiple bills can contain the same text. This could be an identical bill in the opposite chamber or a smaller bill with a section embedded in a larger bill.
Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
Bill Sponsor is currently only finding exact word-for-word section matches. In a future release, partial matches will be included.
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S. 3395 (Introduced-in-Senate)


117th CONGRESS
1st Session
S. 3395


To amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections.

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “Medical Device Integrity Act”.

SEC. 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(b) Guidance.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue draft guidance describing the circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection,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.