FDA Guidance on PCCP AI-Enabled Medical Devices

On August 18, 2025, the FDA issued final guidance for industry on how to include a Predetermined Change Control Plan (PCCP) in marketing submissions for artificial intelligence-enabled device software functions (AI-DSFs). 

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What is a PCCP? 

A PCCP allows manufacturers to outline, in advance, specific modifications they intend to make to an AI-enabled medical device software function. It covers: 

• Description of Modifications – planned changes to the AI model or software. 

• Modification Protocol – methods to develop, validate, and implement those changes safely. 

• Impact Assessment – analysis of benefits, risks, and mitigation strategies. 

Once authorized, these planned changes can be implemented without resubmitting a new 510(k), De Novo, or PMA, provided the modifications follow the approved PCCP. 

Why it Matters 

AI/ML-based medical devices often evolve rapidly through iterative improvements. Traditionally, many of these updates would have required a new FDA submission, creating delays. With an authorized PCCP: 

• Manufacturers gain flexibility to update their AI systems more efficiently. 

• Patients and providers benefit from timely access to improved device performance. 

• FDA oversight is maintained to ensure safety and effectiveness. 

Who is Affected 

The FDA AI PCCP guidance applies to: 

• Manufacturers of AI/ML-enabled devices (Software as a Medical Device or software in a device). 

• Device-led combination products where the device component uses AI. 

• Both automatic (continuous learning) and manual AI updates. 

Key Takeaways for Manufacturers 

• A PCCP must be included as part of the marketing submission (PMA, 510(k), or De Novo). 

• Modifications outside the scope of an authorized PCCP still require a new submission. 

• Labeling must clearly state that the device includes AI with an authorized PCCP and may undergo updates. 

• Early engagement with FDA (via the Q-Submission Program) is encouraged to align expectations. 

How MedEnvoy Can Support 

At MedEnvoy, we help manufacturers navigate regulatory pathways for innovative technologies, including AI-enabled medical devices. Our support includes: 

• Regulatory Strategy Development – assessing whether and how a PCCP should be incorporated into your FDA submission. 

• Submission Preparation – structuring PCCPs with robust descriptions, protocols, and impact assessments aligned with FDA expectations. 

• Labeling & Communication – ensuring device labeling and public-facing documentation meet transparency requirements. 

• Lifecycle Compliance – guiding manufacturers in implementing PCCPs within their quality systems and maintaining alignment with FDA requirements. 

• Global Perspective – advising on how PCCPs fit into broader regulatory frameworks (EU MDR/IVDR, UK, and other markets). 

By combining regulatory expertise with practical experience, MedEnvoy helps you accelerate innovation while ensuring compliance. We encourage you to contact our team for tailored support.