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…
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Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 7, 2022
Referred to the House Committee on Energy and Commerce.
Jul 7, 2022
Introduced in House
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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
Referred to the House Committee on Energy and Commerce.
Related & companion bills
1
Bill text
1 version
- Introduced in House Formatted Text PDF Formatted XML
Committees of jurisdiction
1
Cite this page
U.S. Congress. (2026). H.R. 8299: 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-HR-8299/
"H.R. 8299: 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-HR-8299/.
H.R. 8299, 117th Cong. (2026), https://openamerica.io/bill/117-HR-8299/.
[H.R. 8299: 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-HR-8299/)