Articles tagged with “algorithm-change-protocol”

FDA PCCP Guide for AI/ML Software as a Medical Device

Understand FDA Predetermined Change Control Plans (PCCPs) for AI/ML Software as a Medical Device. Review Section 515C, FDA guidance, and implementation.

40 min read

4/16/2026

fda pccp ai/ml samd software as a medical device medical device regulation algorithm change protocol fda guidance gmlp