H.R. 8299 · 117th Congress
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.
- Stage
- In committee
- Sponsor
- Gus Bilirakis
- Introduced
- 2022-07-07
- Latest action
- 2022-07-07 · Introduced in House
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.