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.
Sponsored By: Representative Bilirakis, Gus M. [R-FL-12]
Unknown
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.
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
No Economic Impacts Identified for this Bill
Sponsors & CoSponsors
Sponsor
Bilirakis, Gus M. [R-FL-12]
FL • R
Cosponsors
Rep. O'Halleran, Tom [D-AZ-1]
AZ • D
Sponsored 7/7/2022
Rep. Kuster, Ann M. [D-NH-2]
NH • D
Sponsored 7/28/2022
Rep. Cárdenas, Tony [D-CA-29]
CA • D
Sponsored 7/28/2022
Rep. Craig, Angie [D-MN-2]
MN • D
Sponsored 7/29/2022
Rep. Rutherford, John H. [R-FL-5]
FL • R
Sponsored 9/29/2022
Rep. DeGette, Diana [D-CO-1]
CO • D
Sponsored 9/29/2022
Rep. Neguse, Joe [D-CO-2]
CO • D
Sponsored 11/14/2022
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov