Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Administrative / Procedural, Digital Health, Premarket
Published
July 17, 2023
Last updated
July 17, 2023
Description
A guidance document on qualifying medical device development tools for industry, tool developers, and FDA staff. Topics include administrative and premarket procedures.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)