United States · Bill · S
S. 3395 (117th)
Medical Device Integrity Act
Introduced
14 December 2021
Last action
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Status
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
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Subjects
Discovery layer
Source updated
21 April 2025
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.
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Votes
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Versions
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Documents
3 official files
Introduced in Senate (text)
Introduced in Senate · EN · 14 December 2021
Introduced in Senate (PDF)
Introduced in Senate · EN · 14 December 2021
Introduced in Senate
summary · EN · 14 December 2021
Sponsors
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Related records
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Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/117th-congress/senate-bill/3395
- Open data entity: https://api.congress.gov/v3/bill/117/s/3395