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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.
12/29/2022, 5:48 PM
Congressional Summary of S 4386
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.
Read the Full Bill
Current Status of Bill S 4386
Bill S 4386 is currently in the status of Bill Introduced since June 13, 2022. Bill S 4386 was introduced during Congress 117 and was introduced to the Senate on June 13, 2022. Bill S 4386's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of June 13, 2022
Bipartisan Support of Bill S 4386
Total Number of Sponsors
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
1Democrat Cosponsors
1Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill S 4386
Primary Policy Focus
HealthAlternate Title(s) of Bill S 4386
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.
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.
Comments
Sponsors and Cosponsors of S 4386
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