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.
United States117th CongressHR-8299House of Representatives
Updated: Jul 7, 2022
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.
Bill texts
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Timeline
Latest companion bill action
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.Introduced in Senate
Introduced in House
Referred to the House Committee on Energy and Commerce.
House of Representatives
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