Articles tagged with “fda-pccp”

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

FDA PCCP Explained: Managing Medical Device Changes

Explore the FDA PCCP framework for medical devices. Understand Section 515C requirements for pre-approving AI/ML software changes without new submissions.

35 min read

2/9/2026

fda pccp medical device regulation ai/ml devices section 515c fdora 2022 software as a medical device regulatory compliance 510(k) submission change management