S. 3395Senate117th Congress (2021-2023)In Committee

Medical Device Integrity Act

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Updated February 8, 2026 at 8:35 AM UTC

The Medical Device Integrity Act amends the Federal Food, Drug, and Cosmetic Act to extend the FDA’s authority to request records related to medical devices, not just drugs. It requires the agency to give a clear description of the records it seeks and explain why it is asking for them instead of conducting an on‑site inspection. The rule applies to the FDA and manufacturers, distributors, and other holders of medical device records.

Key Provisions

Adds “or device” language to the FD&C Act, expanding record‑inspection authority to cover medical devices.
Requires the FDA to provide a sufficient description of requested records and a rationale for requesting them in advance of, or instead of, an inspection.
Mandates the Secretary of Health and Human Services to issue draft and final guidance within set timeframes on how to make such requests, how recipients may respond, and the factors the agency will consider, with attention to small‑business constraints.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

December 14, 2021

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SenateIntro Referral

Introduced in Senate

December 14, 2021

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

December 14, 2021

Bill Text

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Introduced in SenateIssued December 14, 2021

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

(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.