Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Premarket
Published
February 21, 2018
Last updated
August 10, 2023
Description
Guidance document providing answers to frequently asked questions about accepting clinical data for medical device applications and submissions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)