What is a predetermined change control plan (PCCP)?

What does a PCCP contain?

Software that uses artificial intelligence (AI) can change often, for example when a model is retrained on new data. The U.S. Food and Drug Administration (FDA), Health Canada and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) published guiding principles in October 2023. They say some changes to such a device, such as changes to a model or algorithm, can require additional review by a regulator. That expectation, they say, may not always match the rapid pace of development.

A PCCP is a way to agree on changes in advance. The three regulators describe it as a plan, proposed by a manufacturer, that specifies:

• certain planned modifications to a device
• the protocol for implementing and controlling them
• an assessment of their impact

Their five principles say a plan should be focused and bounded, risk based, evidence based and transparent. They say it should also take a total product lifecycle perspective. Planned changes are limited to the intended use of the original device.

How does the FDA use PCCPs?

A law enacted on December 29, 2022 added a section on PCCPs to the Federal Food, Drug, and Cosmetic Act. The FDA announced final guidance on PCCPs for AI-enabled device software on December 4, 2024. Its guidance page lists a version dated August 2025. The agency says it reviews the plan as part of a device's marketing submission. It says the manufacturer then does not need another submission for each modification the plan describes. The recommendations apply to devices reviewed through the 510(k), De Novo and premarket approval pathways. The Federal Register notice says the guidance is not binding on the FDA or the public.

What is the UK planning?

The UK government responded on October 6, 2026 to the National Commission into the Regulation of AI in Healthcare. It said the MHRA intends to issue draft guidance on PCCPs by December 2026, for public comment. The draft would describe a proposed approach that lets manufacturers set boundaries for the scope of allowable change, instead of only prespecifying specific modifications. It would include approaches for adaptive AI-enabled devices while maintaining a device's intended use. As of October 6, 2026, that was a stated intention to publish a draft.