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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…

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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.

Introduced: June 13, 2022 See on congress.gov
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
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 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 June 13, 2022

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Related & companion bills 1
  • HR 8299 Identical bill To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental applicat…
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 1
All 1 Democratic 1
D
Hickenlooper, John W.
Colorado · Jun 13, 2022
Cite this page click to expand
APA
U.S. Congress. (2026). 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.. 117th Congress. Open America. https://openamerica.io/bill/117-S-4386/
MLA
"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.." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-4386/.
Bluebook (legal)
S. 4386, 117th Cong. (2026), https://openamerica.io/bill/117-S-4386/.
Markdown link
[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.](https://openamerica.io/bill/117-S-4386/)
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