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Predetermined Change Control Plans (PCCP)

What is a PCCP?​

A Predetermined Change Control Plan (PCCP) is a plan submitted as part of a premarket submission (510(k), De Novo, or PMA) that:

  1. Describes the types of modifications the manufacturer anticipates making to the device
  2. Specifies the algorithm change protocol — the methods that will be used to implement and validate each type of change
  3. Describes the performance monitoring that will detect when changes are needed and verify that implemented changes perform as expected

A device with an approved/cleared PCCP can implement pre-specified modifications without submitting a new 510(k) for each change — as long as the modifications stay within the bounds of the approved plan.

Why PCCPs matter for AI/ML​

Traditional medical devices are static after clearance/approval. AI/ML-based SaMD, however:

  • Learns from new data and can change its outputs over time ("adaptive AI")
  • May need algorithm retraining to maintain performance as data distributions shift
  • Benefits from incorporating new clinical evidence as it emerges

Without a PCCP, every meaningful algorithm update would require a new 510(k) — making adaptive AI impractical. PCCPs solve this.

PCCP submission types​

PCCPs can be included in:

  • 510(k) submissions (most common for Class II AI/ML SaMD)
  • De Novo requests
  • PMA applications (and PMA supplements)

Required PCCP content (per 2024 FDA guidance)​

1. Description of Modifications​

Clearly describe the types of modifications anticipated:

  • Inputs to the algorithm (new data types, expanded patient populations)
  • Outputs (new predictions, risk scores, confidence levels)
  • Performance specifications (new performance thresholds)
  • Algorithm architecture or training methodology

2. Algorithm Change Protocol (ACP)​

For each type of modification, describe:

  • Data management practices — training and test dataset requirements, data quality, representativeness
  • Re-training practices — frequency, methods, validation approach
  • Performance evaluation protocol — metrics, reference standards, acceptance criteria
  • Transparency and documentation — what records are maintained

3. Impact Assessment​

A pre-specified method to assess whether a contemplated modification:

  • Falls within the scope of the PCCP
  • Requires a new premarket submission (if it exceeds PCCP scope)

What a PCCP does NOT cover​

A PCCP does not authorise:

  • Changes to the device's intended use (new indications always require a new submission)
  • Changes that exceed the scope described in the approved PCCP
  • Changes that raise new questions of safety or effectiveness not addressed in the PCCP

Official resources​