summary
Introduced
12/14/2021
12/14/2021
In Committee
12/14/2021
12/14/2021
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections.
AI Summary
This bill, the Medical Device Integrity Act, amends the Federal Food, Drug, and Cosmetic Act to allow the Secretary of Health and Human Services to request records or other information related to the processing of medical devices, in addition to drugs, before or in lieu of an inspection. The bill also requires the Secretary to issue guidance within one year on the circumstances in which such requests will be made, the process for responding, and factors to be considered in evaluating whether the records are provided in a reasonable manner, accounting for resource and other limitations, particularly for small businesses.
Committee Categories
Health and Social Services
Sponsors (3)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 12/14/2021)
Official Document
bill text
bill summary
Loading...
bill summary
Loading...
bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/senate-bill/3395/all-info |
| BillText | https://www.congress.gov/117/bills/s3395/BILLS-117s3395is.pdf |
| Bill | https://www.congress.gov/117/bills/s3395/BILLS-117s3395is.pdf.pdf |
Loading...