S 3395
117th Congress
Senate
Health
Medical Device Integrity Act
Introduced: December 14, 2021
Introduced by:
Baldwin, Tammy
Democratic
· Wisconsin
See on congress.gov
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
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1
Cosponsors
1