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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.

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.

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

Sen. Braun, Mike [R-IN](R-IN)Sponsor
1 cosponsor1 D
1cosponsors1committees2actions1related bills
  1. IntroReferral

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

    Health, Education, Labor, and Pensions Committee
  2. IntroReferral10000

    Introduced in Senate

A bill to allow for devices with a predetermined change control plan to be marketed witho… — Informed