Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Premarket
Published
January 8, 2024
Last updated
January 8, 2024
Description
This is a guidance document titled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." It focuses on premarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)