FDA GUIDANCE · FINALNovember 26, 2024

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff

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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

Final

Topic

Premarket Approval (PMA), HUD/HDE

Issue date

November 26, 2024

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