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Regulation · standard

FDA Predetermined Change Control Plan (PCCP) Final Guidance

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.

Jurisdiction: United States · Effective 2026-01-01

Machine-readable surfaces

Sources (1)

  1. https://www.fda.gov/medical-devices/software-medical-devices/saMD-pre-cert-pilot-program-and-related-materials

Status history

  • In effect · 2026-01-01 · agent-recon

    Initial ingestion

Common questions

What 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.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Predetermined Change Control Plan (PCCP) Final Guidance.

Canonical ID 27ff06ac-f12d-42ec-a102-a86508337873