S. 3395 · 117th Congress
Medical Device Integrity Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
BaldwinSponsor2 cosponsors · 1 D, 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Dec 14, 2021
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Medical Device Integrity Act
Latest action (Dec 14, 2021): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Dec 14, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.