H.R. 8299 · 117th Congress
To allow for devices with a predetermined change control plan to be marketed without submitting a…
Full title
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.
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BilirakisSponsor7 cosponsors · 6 D, 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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 it does: CRS summary · Introduced in House · Jul 7, 2022
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: 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.
Latest action (Jul 7, 2022): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Jul 7, 2022
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.