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U.S. federal · In effect

FDA final guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

Verified Checked against its sources on 2 sources quoted

Where
United States
Agency
Food and Drug Administration (CDRH, with CBER and CDER)
Instrument
Final guidance (non-binding)
Status
Final guidance; current version dated August 2025 (docket FDA-2022-D-2628)
Issued
December 4, 2024 (Federal Register notice of availability; revised version dated August 2025)
Effective
December 4, 2024 (current version August 2025)
Applies to
Manufacturers of AI-enabled medical devices
Sectors
Healthcare: AI-enabled medical devices
Applicability
AI-enabled devices whose sponsors propose planned modifications
Penalties and enforcement
None in the guidance; devices remain subject to FD&C Act requirements
Enforcing authority
FDA

Summary

FDA final guidance, announced in the Federal Register on December 4, 2024 (docket FDA-2022-D-2628), on predetermined change control plans (PCCPs) for AI-enabled device software functions. A PCCP submitted with a marketing submission describes planned modifications, how they will be developed, validated and implemented, and an assessment of their impact; once FDA authorizes the PCCP, the described modifications can be implemented without a new marketing submission for each. FDA's guidance page now carries a version dated August 2025. Guidance is non-binding.

Key dates

  1. December 4, 2024Issued
  2. October 16, 2026Checked against sources
  3. October 21, 2026Checked against sources

Developments are added when the record is reviewed. Next review: October 16, 2027.

Evidence

Each passage is quoted from its source. The quoted passages are re-checked against the live pages every month.

  1. is announcing the availability of a final guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions."

    Supports: Final guidance and official title

    DATES: The announcement of the guidance is published in the Federal Register on December 4, 2024.

    Supports: Date

    FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.

    Supports: What a PCCP does

    Marketing Submission Recommendations for a PCCP; Availability Federal Register / FDA Primary source

  2. Guidance for Industry and Food and Drug Administration Staff August 2025 Download the Final Guidance Document

    Supports: Current version dated August 2025

    Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions U.S. Food and Drug Administration Primary source

Suggested citation. Eminence Scan, “FDA final guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions”, Eminence Growth Solutions, last verified October 16, 2026, https://eminencegrowthsolutions.com/tools/eminence-scan/record/fed-044/.

Using our research: you may read and quote Eminence Scan with credit to “Eminence Scan, Eminence Growth Solutions” and a link; all other rights reserved. Terms: Using our research.

Spotted an error, or a development we have missed? Report a correction. How we check records: research methodology.