Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Animal & Veterinary, Medical Devices
Topics
Premarket
Published
July 9, 2021
Last updated
August 9, 2021
Description
This document provides technical guidance for the premarket assessment of medical devices containing Nitinol for industry and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)