Comments: US SB4386 | 2021-2022 | 117th Congress

Bill Title: 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.

Spectrum: Bipartisan Bill

Status: (Introduced - Dead) 2022-06-13 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. [SB4386 Detail]

Text: Latest bill text (Introduced) [PDF]

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