Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Premarket
Published
September 7, 2023
Last updated
September 6, 2023
Description
Draft guidance document for industry and FDA staff on using clinical data in premarket notification submissions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)