S 4386
117th Congress
Senate
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: June 13, 2022
See on congress.gov
Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 13, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 13, 2022
Introduced in Senate
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1
Cosponsors
1