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FDA Final Guidance — Predetermined Change Control Plans for AI-Enabled Device Software

United States (Federal) | FDA-2023-D-1214 (Final Guidance)

Year Enacted
2024
Date Signed
Dec 3, 2024
Effective Date
Dec 3, 2024
Status
Enacted
Final guidance published December 3, 2024; non-binding but represents FDA current regulatory expectations

Categories

Provider Clinical Use

Key Requirements

Provides recommendations for PCCPs specific to AI-enabled device software functions. Requires descriptions of planned modifications, validation protocols, and impact assessments. Addresses data categories (training, tuning, and testing), labeling and transparency requirements, and risk management. Manufacturers must disclose when a device has been authorized with a PCCP.

Regulated Parties

Manufacturers of AI-enabled medical devices seeking 510(k), De Novo, or PMA clearance

Enforcement

FDA (Center for Devices and Radiological Health)

Sources

Official https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial

Notes

Implements the FDORA Section 3308 statutory authority. Expands scope from ML-only to all AI-enabled devices.

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