FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices
[in effect]United States · safety standard · safety standard
Jurisdiction
United States
Classification
safety standard
Status
in effect
Effective Date
Dec 1, 2024
Primary Sources
1 audited
Statutory Scope & Summary
FDA finalized guidance on Predetermined Change Control Plans (PCCPs), allowing AI/ML medical device manufacturers to make pre-approved modifications without full resubmission. Requires documented modification protocol, impact assessment, and post-market monitoring. Over 1,350 AI-enabled devices authorized by FDA as of 2026.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices cover?
FDA finalized guidance on Predetermined Change Control Plans (PCCPs), allowing AI/ML medical device manufacturers to make pre-approved modifications without full resubmission. Requires documented modification protocol, impact assessment, and post-market monitoring. Over 1,350 AI-enabled devices authorized by FDA as of 2026.
Where does FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices apply?
FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices is recorded as a safety_standard applying in United States on the DEPLOY registry.
When did FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices take effect?
FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices is recorded as effective December 1, 2024 on the DEPLOY registry.
Is FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices still in effect?
FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices apply to?
FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices is recorded as applying to surgical, biometric, wearable on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices?
8 robot models on the DEPLOY registry match the form-factor scope of FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices: AI Pin, ANOVO, AirGo Vision, Amazfit (Balance / Active / T-Rex / Helio) and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Primary Sources & Legal Instruments
1 document- https://www.ropesgray.com/en/insights/alerts/2024/12/fda-finalizes-guidance-on-predetermined-change-control-plans-for-ai-enabled-deviceOfficial Source
https://www.ropesgray.com/en/insights/alerts/2024/12/fda-finalizes-guidance-on-predetermined-change-control-plans-for-ai-enabled-device