510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Administrative / Procedural, Premarket
Published
December 21, 2023
Last updated
December 20, 2023
Description
Draft guidance document for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review by the FDA.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)