Skip to main content
HR 8299 117th Congress House 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.

Introduced: July 7, 2022 Introduced by: Bilirakis, Gus M. Republican · Florida See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 7, 2022
Referred to the House Committee on Energy and Commerce.
Jul 7, 2022
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now July 7, 2022

Referred to the House Committee on Energy and Commerce.

 Committees of jurisdiction 1