Medical Device Integrity Act

12/30/2022, 3:34 AM

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.

Congress
117
Number
S - 3395
Introduced on
2021-12-14
# Amendments
0
Sponsors
+5
Cosponsors
+5

Variations and Revisions

12/14/2021
Text
PDF
XML

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and 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.

Alternative Names
Official Title as IntroducedA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections.
Policy Areas
Health

Comments

Recent Activity

Latest Summary7/21/2022

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. Cu...

Latest Action12/14/2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.