Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Digital Health, Premarket
Published
April 3, 2023
Last updated
March 30, 2023
Description
This document is a draft guidance for the FDA and industry staff on marketing submission recommendations for AI/ML-enabled device software functions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)