ARTICLE SUMMARY:
Predetermined change control plans have quickly moved from an experimental concept to a practical regulatory tool in recent years, with several dozen FDA authorizations, and growing, employing PCCPs to streamline future device modifications. We look at some examples of the practice, how the strategy might evolve, and the importance of being proactive and detail oriented.
Predetermined change control plans (PCCPs) are a very new concept in the world of medtech regulation, but the approach—in which FDA can sign off in advance on a manufacturer’s future device modifications—is increasingly showing up in active regulatory submissions, and in FDA authorizations.
A PCCP is a mechanism by which a manufacturer can map out a detailed plan for updating a device after it gains a 510(k), De Novo, or PMA in a manner that would typically require a new 510(k) or PMA supplement. The company’s plan must detail how it will carry out the changes and how it will validate post-modification safety and performance. If FDA is convinced the company can make the changes and still ensure safety and effectiveness without changing the fundamental intended use of the device, it can authorize the PCCP, allowing the company to move forward with the planned changes as appropriate without further agency review.
The PCCP is most frequently characterized as a tool to address evolving artificial intelligence/machine learning (AI/ML) algorithms. FDA formally introduced the PCCP concept in a 2019 discussion paper proposing ideas for regulating AI/ML devices. In 2020, the agency granted its first PCCP (via a De Novo authorization), permitting the manufacturer to employ planned algorithm updates to an imaging software device (Caption Guidance) without having to submit new 510(k)s. And last year, FDA published a draft guidance laying out how companies can incorporate the change-control approach into submissions for AI/ML devices.
But the agency has also been making it increasingly clear PCCPs can be valuable to address other types of modifications that are not restricted to AI or even just software-driven devices. In 2022, Congress approved legislation granting FDA explicit authority to authorize PCCPs as part of PMAs and 510(k)s for any type of device. And earlier this year, the agency published a second draft guidance outlining how it could pre-vet planned device updates more broadly.
