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.
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.
Bill status
in committee
1 of 4 stages cleared
Introduction
Jun 2022
Committee Review
Floor Vote
President
Introduced Jun 13, 2022
Last action Jun 13, 2022
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Jun 13, 2022
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Jun 13, 2022
Introduced
Introduced in Senate
upper
1 primary · 1 co-sponsor
Sponsors
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