FDA Updates the Regulatory Definitions of Certain Software Types for Consistency with 21st Century Cures Act Exclusions
FDA Law Blog
APRIL 20, 2021
Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. By McKenzie E. Certain types of clinical decision-support software. Medical Image Storage Device.
Let's personalize your content