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Regulation · Safety standard

FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices

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.

Jurisdiction: United States · Effective 2024-12-01

Machine-readable surfaces

Sources (1)

  1. https://www.ropesgray.com/en/insights/alerts/2024/12/fda-finalizes-guidance-on-predetermined-change-control-plans-for-ai-enabled-device · 2024-12-01

Status history

  • In effect · 2024-12-01 · agent-recon

    Initial ingestion

Common questions

What 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.
Methodology: Unreviewed · 1 source (no 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
unclassified
Unclassified source

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

Methodology surface for FDA Final Guidance: Predetermined Change Control Plans for AI/ML-Enabled Devices.

Canonical ID f53f5fb8-da84-4cf2-ad8d-2b4a3af5dc01