Title: Medical Device Integrity Act
Policy area: Health

Summary:
Medical Device Integrity Act
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.
The bill also requires the FDA to include in its requests a rationale for requesting the information in question.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3395 Introduced in Senate (IS)]

<DOC>






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.
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