
FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions
The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of […]