A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections.
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.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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