S 4386 · 117th Congress · 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.

Introduced 2022-06-13· Sponsored by Sen. Braun, Mike [R-IN]· Senate

Bill Progress

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Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.(2022-06-13)

Plain Language Summary

[AI summary unavailable — showing source text] 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.…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (1)

1 Democrat
Sen. Hickenlooper, John W. [D-CO]CO