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- H.R.8299
H.R.8299: 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 July 7, 2022
- Latest Major Action July 7, 2022
Bill Sponsor
Bill Cosponsors
7 (6 Democrats, 1 Republican)
Bill Version
- Introduced in House - July 7, 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 |
|---|---|
| July 7, 2022 |
Referred to the House Committee on Energy and Commerce.
|
| July 7, 2022 |
Introduced in the House by Gus Bilirakis (R-Fla.) |