FDA PCCP Guidance For AI/ML Medical Devices: 2026 Submission & Change Control Guide

Medical device software no longer stays the same after launch. AI models improve, new clinical data becomes available, and performance can change over time. For manufacturers, the real challenge is not just building an effective AI-enabled device, but deciding how future updates will fit into FDA regulatory compliance without creating unnecessary regulatory hurdles.

One detail is worth clearing up from the beginning. An FDA PCCP (Predetermined Change Control Plan) is not something every AI medical device needs. It is an optional approach that manufacturers can use in specific situations. FDA published the final guidance on December 3, 2024, and the current guidance document is dated August 18, 2025, so older draft guidance should not be treated as the current framework.

If you are preparing an AI device submission, understanding when a PCCP makes sense is only the starting point. The bigger question is what the FDA expects you to document so future changes remain predictable, justified, and easier to manage. That is exactly what this guide covers.

Authorized under Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) / Section 515C of the FD&C Act, an FDA PCCP establishes explicit prospective boundaries for post-market software changes.



Source: https://qualysec.com/fda-pc ...