FDA GUIDANCE · DRAFTAugust 22, 2024

Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

What this record is not

Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Draft

Topic

Premarket

Issue date

August 22, 2024

This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

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