Medical Device Integrity Act

Senate Bill 3395 - Medical Device Integrity Act: Overview, Status, and Impact

Hozzl · 2022-12-30T03:34:01Z

Explore the details of Senate Bill 3395 Medical Device Integrity Act currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

12/30/2022, 3:34 AM

Congressional Summary of S 3395

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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Current Status of Bill S 3395

Bill S 3395 is currently in the status of Bill Introduced since December 14, 2021. Bill S 3395 was introduced during Congress 117 and was introduced to the Senate on December 14, 2021. Bill S 3395's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of December 14, 2021