Accelerating innovation with Predetermined Change Control Plans

• Predetermined Change Control Plans (PCCPs) are an emerging regulatory concept for medical devices and in vitro diagnostics (IVDs) that many mature regulators are using or contemplating
• The streamlined approach offered by PCCPs applies to a broad range of devices, including AI/ML-enabled devices as well as traditional devices and IVDs
• Stakeholder collaboration is key to maximizing the potential for continuous improvement and innovation in medical devices

Innovation in medical devices and in vitro diagnostics (IVDs), particularly in artificial intelligence (AI) and machine learning (ML) -enabled solutions, is moving at an increasingly rapid pace.¹ In 2015 the Food and Drug Administration (FDA) authorized six AI medical devices, but by 2023 this number had risen to 221 devices.²

In order to balance this rate of progress with safety and efficacy, it is vital that regulatory pathways accommodate and accelerate access to new technologies. Predetermined Change Control Plans (PCCPs) offer a pragmatic approach by allowing regulators to pre-authorize intended modifications within clear parameters, ensuring products remain safe and effective.

While PCCPs provide regulatory benefits, the adoption of this solution by manufacturers is not yet commonplace. Of 3,000 510(k)^* premarket notification submissions to the FDA in 2024, only 41 included PCCPs.³

Nick Decker, Head of Regulatory Policy for Global Standards, Postmarket, and Translational Policy at Roche Diagnostics, believes PCCPs are a valuable regulatory concept for bringing timely, safe innovations to market. Here, he gives his thoughts on the benefits to patients, regulators and manufacturers alike in adopting PCCPs. He dispels common misconceptions about their applications and identifies the need for continued collaboration across stakeholders to further advance their effectiveness, efficiency, and use.

HT: Can you tell us how PCCPs contribute to the continuous improvement of devices?

Nick Decker: PCCPs offer a structured approach that requires thorough planning, risk assessment, and regulatory approval with the initial market authorization of a device or IVD.⁴ Once approved, manufacturers can implement predefined changes according to the approved protocol without having to resubmit the product for market authorization, thereby reducing the time it takes to bring innovative improvements to market for patient use. If we look at an AI/ML-enabled device for example, an approved PCCP may be used to introduce new data sources into the model which can result in the model being better suited for particular patient subpopulations. Without a PCCP, the introduction of a new data source would likely require a new submission, slowing patient access.

HT: Can you give a practical example of the thinking behind implementing PCCPs?

Nick Decker: Think of a PCCP as a city’s urban development blueprint. When a city plans for future expansion, it doesn’t wait for roads to become dangerously congested before taking action—or at least it shouldn’t. Instead, it establishes a detailed framework for adding new roads, bridges, and public transit systems. Before future expansions can happen, urban planners assess new risks, environmental impacts, and public safety concerns. Similarly, PCCPs for medical devices and IVDs establish a sort of roadmap for implementing planned changes according to an appropriately rigorous change protocol approved by the regulator.

PCCPs are designed to create regulatory efficiency that balances regulatory rigor with innovation to ensure access to safe and effective devices for patients. By leveraging PCCPs and consolidating the regulatory review process, patients can benefit from new features, improved diagnostics, and personalized solutions. Regulators can streamline regulatory resources. Just as urban planners anticipate growth to avoid congestion, PCCPs help medical device manufacturers and regulators stay ahead, optimize efficiency, and ensure that safe, timely innovations reach patients.

HT: Are PCCPs a shortcut for manufacturers to make changes to their devices without oversight?

Nick Decker: PCCPs are not a shortcut. PCCPs are a regulatory tool that allow regulators to do the same review in a consolidated way prior to the marketing of the device, rather than requiring a subsequent submission.

It is critical that all stakeholders, especially patients, understand that PCCPs are not a ‘carte blanche’ tool that allows manufacturers to make changes to devices without oversight or change controls in place. Regulators retain the ability to ensure each modification meets the necessary safety and efficacy standards. It’s also important to remember that PCCPs are reviewed and approved by regulators, and all changes are strictly implemented according to the change protocol. Thoughtful planning is essential to the development of a PCCP and regulators are correct to expect appropriate documentation in order to approve it. Of course, if this documentation is too onerous or unavailable in the premarket phase, the scope and thus the value of the PCCP will decrease.  Regulators should balance the policy goal of enabling more agile change management with the need for PCCP requirements in order to preserve the value of the concept.

HT: Are there limitations to what changes can be made under a PCCP?

Nick Decker: Imagine a company makes a car designed to be driven on well-planned roads. Suppose the car has an AI system that helps with navigation. The manufacturer can use the PCCP to improve the navigation system, perhaps making it better at predicting traffic by using new data sources. This is still within the scope of the navigation system’s original intended use and doesn’t fundamentally change what the system is used for. However, if the manufacturer decides to use this system to turn the car into a self-driving car, this is a change in its intended use. That kind of a change in the context of a medical device might look like modifying a diagnostic imaging technology to include a therapeutic ability. Any significant change in the intended use of a device would make it ineligible for a PCCP. One of the distinguishing features of eligibility for PCCPs is that the intended use must remain the same.

HT: Why is there such a strong focus on AI/ML-enabled devices when discussing PCCPs?

Nick Decker: It makes sense that PCCPs were first envisioned with AI/ML-enabled devices in mind because of their rapid development relative to traditional medical devices. Such a regulatory approach is necessary to advance innovation for AI/ML-enabled devices in particular, but this can also be applied more broadly to advance innovation for other devices as well. The number of authorized AI/ML devices is still significantly lower than the number of traditional devices. By August 2024, around 950 AI/ML devices had been authorized for marketing in the U.S. By comparison, the overall number of authorized devices in 2022 was nearly 6,000.^2,5

We’ve seen some positive steps, in particular with the FDA publishing a draft guidance for PCCPs, which noted that ‘While it is important for regulatory frameworks to accommodate new technologies, it is also important for such frameworks to be robust and useful across a broad range of devices and applications^.’6 This approach should ensure that PCCPs bring benefits beyond AI/ML devices to other medical technologies that need similar streamlined regulatory processes.

HT: What is your perspective on extending PCCPs to other devices?

Nick Decker: If you think of PCCPs for AI devices only, you’re excluding a huge chunk of devices and IVDs that would benefit from PCCPs, advancing innovation and efficiently using regulatory resources. By excluding traditional devices, we are unnecessarily slowing innovation for medical devices and IVDs overall, burdening regulators by limiting their flexibility and delaying patient and provider access to new and improved products.

HT: Why is collaboration between stakeholders crucial to the successful implementation of PCCPs?

Nick Decker: Developing precise change plans, ensuring robust validation and risk assessment protocols, and navigating new PCCP regulations for medical devices comes with challenges and requires time and resources.³ To work through these challenges and maximize opportunities for innovation, stakeholders must align throughout the process. The definition and application of PCCPs must also be aligned globally. The more PCCPs have in common across jurisdictions, the more agility will be unlocked.

Close collaboration among different stakeholders helps manufacturers, regulators, and business leaders understand that PCCPs are a powerful regulatory tool that enables efficient, and well-regulated changes that accelerate innovation while maintaining public trust and patient safety.

*A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective, that is, substantially equivalent, to a legally marketed device.