S. 4386 · 117th Congress · Senate

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.

Active· Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced
Jun 13, 22
Passed Senate
Pending
Passed House
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

2
  1. JUN 13, 2022•IntroReferral

    Introduced in Senate

  2. JUN 13, 2022•IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Committees

1

Health, Education, Labor, and Pensions Committee

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Referred: Jun 13, 2022

Active