General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket
Published
March 28, 2023
Last updated
March 27, 2023
Description
A guidance document for industry and FDA staff on conducting animal studies to evaluate medical devices, covering IDE and premarket topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)