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- S.4386
S.4386: A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
About This Bill
- This bill was introduced in the 117th Congress
- This bill is primarily about health
- Introduced June 13, 2022
- Latest Major Action June 13, 2022
Bill Sponsor
Bill Cosponsor
Bill Version
- Introduced in Senate - June 13, 2022
Bill Summary
This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.
(Source: Library of Congress)
Bill Actions
Date | Description |
---|---|
June 13, 2022 |
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
|
June 13, 2022 |
Introduced in the Senate by Mike Braun (R-Ind.) |