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.

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.

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Related Legislation

S. 4386A 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.
2022-06-13Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Legislative Actions

2022-07-07
Introduced in House
2022-07-07
Introduced in House
2022-07-07
Referred to the House Committee on Energy and Commerce.

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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