0
0
0
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
Latest Bills
ADS for Mental Health Services Act
Bill S 414December 10, 2025
ASCEND Act
Bill S 1437December 10, 2025
Reliable Federal infrastructure Act
Bill HR 4690December 10, 2025
SHOWER Act
Bill HR 4593December 10, 2025
Dismissing the election contest relating to the office of Representative from the Fourteenth Congressional District of Florida.
Bill HRES 312December 10, 2025
Dismissing the election contest relating to the office of Representative from the Thirtieth Congressional District of Texas.
Bill HRES 311December 10, 2025
Dismissing the election contest relating to the office of Representative from the at-large Congressional District of Alaska.
Bill HRES 310December 10, 2025
Dismissing the election contest relating to the office of Representative from the Twenty-eighth Congressional District of Texas.
Bill HRES 309December 10, 2025
Dismissing the election contest relating to the office of Representative from the Fourteenth Congressional District of Florida.
Bill HRES 308December 10, 2025
To designate the facility of the United States Postal Service located at 300 Macedonia Lane in Knoxville, Tennessee, as the "Reverend Harold Middlebrook Post Office Building".
Bill HR 1372December 10, 2025
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.
Bill HR 8299December 29, 2022