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S 3395 117th Congress Senate Health

Medical Device Integrity Act

Introduced: December 14, 2021 Introduced by: Baldwin, Tammy Democratic · Wisconsin See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 14, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 14, 2021
Introduced in Senate
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 Plain-English summary Congressional Research Service

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.

What's happening now December 14, 2021

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

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 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 1
All 1 Republican 1
R
Cassidy, Bill
Louisiana · Dec 14, 2021
Cite this page click to expand
APA
U.S. Congress. (2026). S. 3395: Medical Device Integrity Act. 117th Congress. Open America. https://openamerica.io/bill/117-S-3395/
MLA
"S. 3395: Medical Device Integrity Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-3395/.
Bluebook (legal)
S. 3395, 117th Cong. (2026), https://openamerica.io/bill/117-S-3395/.
Markdown link
[S. 3395: Medical Device Integrity Act](https://openamerica.io/bill/117-S-3395/)
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