July 12, 2025

Artificial Intelligence (AI) is changing healthcare—from imaging to patient monitoring. But updating software safely and staying within regulations can be tricky. The FDA’s Predetermined Change Control Plan (PCCP) helps solve this problem.

Released in December 2024, the PCCP allows companies to update AI software in medical devices without submitting a new application each time, as long as changes follow the pre-approved plan.

 

What is a PCCP?

A PCCP is a pre-submitted and FDA-reviewed plan that shows how a company will improve its AI algorithm over time. Instead of freezing updates after approval, it allows safe, ongoing improvements while keeping patients safe.

 

Three Key Parts of a PCCP

Description of Changes

  • Explains what changes are expected and how they fit the device’s purpose.
  • Ensures updates are clear and intentional.

Modification Plan

  • Details how updates will be developed, tested, validated, and applied.
  • Includes steps like data input, algorithm retraining, and performance checks.

Impact Assessment

  • Evaluates risks, benefits, and how to manage any problems.
  • Shows that updates won’t harm safety or effectiveness.

 

Who Should Use PCCPs?

Applies to devices with AI software.

Does not cover drugs or biologics in combination products.

Submitted as part of the original application and reviewed with the device approval.

 

Why PCCPs Are Important

  • Faster Innovation: No need to re-submit for every change.
  • Regulatory Clarity: Clear process for updates.
  • Patient Safety: Updates are controlled and safe.
  • Market Flexibility: Respond quickly to clinical needs or new data.
  • Transparency: Updated labels keep users and doctors informed.

 

Best Practices and FDA Advice

  • Use the Q-Submission Program to talk to FDA early.

Maintain a strong quality system:

  • Follow ISO 13485 and FDA QSR standards.
  • Keep good design controls and version tracking.
  • Ensure data governance.
  • Update device labels with approved changes.

 

Challenges

  • Evaluate risks for each change carefully.
  • Keep detailed records and standardized protocols.
  • Follow accepted AI validation standards.
  • Work closely between AI teams, regulatory, and QA.

 

The Future of AI in Healthcare

PCCPs show that the FDA is moving from static approvals to lifecycle oversight. AI is always evolving, so regulations must adapt too.

Companies using PCCPs can update software faster, stay compliant, and show commitment to patient safety. This is a big advantage in the fast-moving digital health market.

 

Conclusion

The FDA’s PCCP guidance is a turning point for AI medical devices. Pre-approved updates let companies innovate while keeping patients safe. Manufacturers should engage regulators early, improve internal processes, and build PCCPs for safe, ongoing AI improvements.