Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
International, Premarket
Published
December 8, 2017
Last updated
March 18, 2021
Description
This document is a guidance for industry and FDA staff on the clinical evaluation of Software as a Medical Device (SAMD).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)