Guidance · U.S. Food and Drug Administration

FDA AI-enabled device software functions and PCCP

FDA recommendations for AI-enabled device software functions, including optional predetermined change control plans (PCCPs) reviewed with a marketing submission. Not a certification standard.

Status: Lifecycle/marketing-submission guidance draft January 2025; PCCP guidance final August 2025
Last reviewed: 15 October 2026
Last verified: 15 October 2026
Industries: Medical devices

What it is

FDA’s draft guidance Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (January 2025) provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA’s evaluation of safety and effectiveness. The page labels it Draft Guidance and Not for implementation. Contains non-binding recommendations.

The final guidance Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025) provide[s] recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. A PCCP should describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for an AI-enabled device so that those planned modifications can proceed without necessitating additional marketing submissions for implementing each modification described in the PCCP.

The recommendations apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways.

What it is not

The January 2025 lifecycle document is draft and not for implementation. Neither page is IEC 62304 or an EU MDR certificate. We have not found an official FDA sentence that treats a PCCP as a product certification or as a substitute for a marketing submission for the device itself.

How it relates to other frameworks

IEC 62304. Software life-cycle processes for medical device software. Different issuer.
EU MDR + AI Act. Union market-access rules. FDA guidance does not apply those regulations.

Primary sources

Read the draft lifecycle guidance and the final PCCP guidance.

Sources

Sources last checked on 15 October 2026.