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.
USA117th CongressHR-8299| House
| Updated: 7/7/2022
Gus M. Bilirakis
Republican Representative
Florida
Cosponsors (7)
Energy and Commerce Committee
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
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.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
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.
USA117th CongressHR-8299| House
| Updated: 7/7/2022
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.
View Full TextSuggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Gus M. Bilirakis
Republican Representative
Florida
Cosponsors (7)
Energy and Commerce Committee
Health
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted