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.
USA117th CongressS-4386| Senate
| Updated: 6/13/2022
Mike Braun
Republican Senator
Indiana
Cosponsors (1)
Health, Education, Labor, and Pensions 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 Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
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.
USA117th CongressS-4386| Senate
| Updated: 6/13/2022
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 Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mike Braun
Republican Senator
Indiana
Cosponsors (1)
Health, Education, Labor, and Pensions Committee
Health
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted