_Regulation · Safety standard_

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

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

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `safety_standard`
- **Status (derived):** in_effect
- **Effective:** 2024-12-01

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.

## 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.


_API: GET /v1/regulations/f53f5fb8-da84-4cf2-ad8d-2b4a3af5dc01 · sources: /v1/regulations/f53f5fb8-da84-4cf2-ad8d-2b4a3af5dc01/sources · status: /v1/regulations/f53f5fb8-da84-4cf2-ad8d-2b4a3af5dc01/status · canonical URL: /regulations/fda-pccp-final-guidance-2024_