FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions

On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" (hereinafter "draft guidance") proposing an approach to support iterative improvement through modifications to a machine learning device software function (ML-DSF) while continuing to provide reasonable assurance of device safety and effectiveness. FDA is accepting comments on the draft guidance until July 3, 2023.

Background:

Historically, changes to an approved or cleared medical device that could significantly affect the safety or effectiveness of the device or that constitute a major change or modification in the intended use of the device required submission of a new 510(k). This framework is at odds with the use of artificial intelligence and machine learning in medical devices, which enable and encourage continuous improvements and