Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Outbreak
Published
May 6, 2024
Last updated
April 29, 2024
Description
Draft guidance document discussing enforcement policies for tests during a Section 564 declared emergency, aimed at industry and FDA staff. Focuses on outbreak-related topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)