Medical Device Integrity Act

2021-12-14

Introduced in Senate

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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