Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Electronic Submissions, Premarket
Published
August 23, 2024
Last updated
August 22, 2024
Description
Guidance document outlining the electronic submission template for medical device De Novo requests, aimed at industry and FDA staff. Focus on electronic submissions and premarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)