H.R. 8299 · 117th Congress · House

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.

Active· Referred to the House Committee on Energy and Commerce.
Introduced
Jul 7, 22
Passed House
Pending
Passed Senate
Pending
Sent to President
Pending
Signed into Law
Pending

Executive 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.

Action Timeline

3
  1. JUL 07, 2022•IntroReferral

    Introduced in House

  2. JUL 07, 2022•IntroReferral

    Introduced in House

  3. JUL 07, 2022•IntroReferral

    Referred to the House Committee on Energy and Commerce.

Committees

1

Energy and Commerce Committee

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Referred: Jul 7, 2022

Active