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
Jul 2022
Committee Review
Floor Vote
President
Introduced Jul 7, 2022
Last action Jul 7, 2022
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Jul 7, 2022
Committee
Referred to the House Committee on Energy and Commerce.
lower
Jul 7, 2022
Introduced
Introduced in House
lower
1 primary · 7 co-sponsors
Sponsors
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