Understanding the PCCP for Non-AI Medical Devices

Introduction

If you’ve been following the regulatory developments around AI in the past 7 years, you will be aware of the landmark PCCP (Predetermined Change Control Plan) guidance document from the FDA. The FDAs initial versions of this framework was to allow more rapid development of AI-enabled device software functions (AI-DSF), but in its final draft and law it was expanded to cover all medical devices. While only the FDA currently has a statutory PCCP framework, both Health Canada and MHRA are working toward similar mechanisms through joint initiatives with FDA and IMDRF.

What is the PCCP and Why does it Matter for Non-AI Devices?

The PCCP is a framework that allows companies to make modifications to medical devices without needing another FDA submission. As a part of your initial FDA submission, you will submit a PCCP which outlines how you plan to modify your medical device (in alignment with the framework), effectively enabling the FDA to grant clearance to the development process, not just the device (within defined limits). This is obviously groundbreaking for AI-DSF which can have rapid iteration and improvement schedules, it’s groundbreaking for all medical devices. No longer do you need to wait 6 months till your next submission to deploy modifications which don’t impact intended use or safety. 

What can I Modify Without Another Submission?  

At a macro level it all revolves around these three questions: 

• Does your modification create a major change or modification, or intended use? 

• Does your modification significantly affect the safety of the device? 

• Does your modification introduce a new risk or significantly modify an existing risk? 

If you answer no to those questions, your modification “may be generally appropriate” for the PCCP protocol. This is deliberately cautious wording, meaning you will still need a Q-sub to align with the FDA. 

As with all guidance there are practical examples in the appendices of appropriate changes. 

Which Modifications Qualify Under the PCCP? 

The FDA has left some leeway in the wording and there is scope to what is “appropriate” or “significant”. For example, at a previous company we had permission through a Q-sub that under the PCCP framework we could change ECG devices in our platform as long as they were in line with performance we had specified and we validated its performance appropriately (I will elaborate more later). We did this because an upgraded version of the ECG device we were currently using was due to be released around 3 months after our predicted clearance date. 

How do I Implement my PCCP? 

You’ll be unsurprised to hear that any modifications through the PCCP will have to be documented in line with your QMS procedures. You will need to update your software spec, risk analysis, DTMs etc. But for the PCCP specifically you will need to describe the modifications and the modification protocol.  

How Should I Describe Device Modifications in my PCCP?

Here you should outline your planned modifications to the device including specifications for the characteristics and performance. The FDA recommends that you list the individual proposed device modifications as well as the rationale of the change for each part of the device they modify. These modifications and specifications need to be very granular, you won’t be able to say: “We will improve the look of the device for new customers”.  

 Any descriptions will need to be very specific: “We will change the housing material from ABS plastic to medical-grade polycarbonate to improve durability and sterilization compatibility, which we expect will extend device life and maintain safety under repeated cleaning cycles.”.   

Any modifications need to be verifiable and validatable with a discussion of the appropriateness of the testing methodologies. 

What Belongs in the Modification Protocol?

The protocol describes the methods that will be followed when developing, validating and implementing modifications. The goals for the protocol outlined in the guidance are:

1. Identify the appropriate and applicable data, test methods, analysis methods and acceptance criteria used to develop and implement the modifications. 
2. Identify the update process and plans for communication/training for users. 
3. Update your QMS inline with changes as if it were a normal FDA submission (including risk management, PMS, UAT and labelling) 
4. Ensure the risks and mitigations strategies have been identified in an impact assessment 
5. Make modifications traceable for the FDA to review. 

Once again this needs to be very specific. Following on from my ECG example above I needed to specify: 

1. Specific leads. 
2. Minimum sample rates. 
3. Minimum battery life. 
4. Acceptable communication protocol changes and rationale. 
5. Resample methods, verification and validation criteria. 
6. User acceptance testing. 
7. Validation of algorithmic performance on downstream tasks and acceptable deviations (still compliant with 60601-2-47). 
8. Labelling, training and messaging procedures for the updates. 

Of note, if there are multiple modifications being presented, any impact assessments, risk assessments or verification protocols not only have to discuss the individual modifications and how they impact the device, but joint modifications and the cumulative modifications as well.  

Why do a PCCP? 

While it may seem daunting to anticipate every potential change, a good PCCP can save you time and reputation. Here are some of the reasons:  

1. Streamlined Regulatory Pathway: Without a PCCP, every meaningful modification (materials, sensors, firmware updates, labeling changes) may trigger a new 510(k) or PMA supplement. 
2. Supports Lifecycle Management: PCCPs give a structured way to manage planned updates, ensuring smoother post-market evolution while still staying within FDA’s guardrails. 
3. Reduced Risk of Compliance Gaps: Making small but repeated changes without a PCCP can lead to uncertainty about whether each one “requires a new submission”. If it’s in the PCCP you’re covered. 
4. Competitive Advantage: Faster time to market and more predictable regulatory strategy. 
5. Faster problem resolution: If you’ve got a bug or issues that are causing problems with customers, the PCCP is a great pathway to ship fixes fast. 
6. Alignment with FDA’s Quality Systems: PCCPs dovetail with the QMSR (Quality Management System Regulation) coming in 2026, which harmonises with ISO 13485. 

Overall the PCCP is a great addition to the regulatory framework and should help you innovate much faster. 

References 

FDA Draft Guidance
Title: Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff 

Issuer: U.S. Food and Drug Administration, Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) (in consultation with CDER and OCP) 

Date: August 22, 2024 

Docket Number: FDA‑2024‑D‑2338 

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