FDA Predetermined Change Control Plan (PCCP) Final Guidance
[in effect]United States · standard · standard
Jurisdiction
United States
Classification
standard
Status
in effect
Effective Date
Jan 1, 2026
Primary Sources
1 audited
Statutory Scope & Summary
FDA finalized guidance on Predetermined Change Control Plans for AI/ML-enabled medical devices, allowing manufacturers to make pre-approved modifications to algorithms without new 510(k) submissions. Requires transparency, monitoring, and risk assessment.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA Predetermined Change Control Plan (PCCP) Final Guidance cover?
FDA finalized guidance on Predetermined Change Control Plans for AI/ML-enabled medical devices, allowing manufacturers to make pre-approved modifications to algorithms without new 510(k) submissions. Requires transparency, monitoring, and risk assessment.
Where does FDA Predetermined Change Control Plan (PCCP) Final Guidance apply?
FDA Predetermined Change Control Plan (PCCP) Final Guidance is recorded as a standard applying in United States on the DEPLOY registry.
When did FDA Predetermined Change Control Plan (PCCP) Final Guidance take effect?
FDA Predetermined Change Control Plan (PCCP) Final Guidance is recorded as effective January 1, 2026 on the DEPLOY registry.
Is FDA Predetermined Change Control Plan (PCCP) Final Guidance still in effect?
FDA Predetermined Change Control Plan (PCCP) Final Guidance is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA Predetermined Change Control Plan (PCCP) Final Guidance apply to?
FDA Predetermined Change Control Plan (PCCP) Final Guidance is recorded as applying to surgical, biometric, wearable on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA Predetermined Change Control Plan (PCCP) Final Guidance?
8 robot models on the DEPLOY registry match the form-factor scope of FDA Predetermined Change Control Plan (PCCP) Final Guidance: 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.fda.gov/medical-devices/software-medical-devices/saMD-pre-cert-pilot-program-and-related-materialsOfficial Source
https://www.fda.gov/medical-devices/software-medical-devices/saMD-pre-cert-pilot-program-and-related-materials