By Shawn M. Schmitt
Communications Specialist, Enzyme
A Predetermined Change Control Plan (PCCP) submitted to and approved by the US Food and Drug Administration (FDA) as part of the medical device review process can give some manufacturers a leg up by shaving months off of the time it can take for a product to come to market, two MedTech industry experts suggest.
A PCCP is documentation that is part of a company’s device submission to FDA reviewers that describes “what modifications will be made to a device and how the modifications will be assessed” so a new 510(k) or a premarket approval (PMA) supplement isn’t needed for a product every time an update is needed, the agency says in its August 2024 draft guidance document on the topic. As an FDA initiative, PCCP was given the green light by Congress in 2022 when lawmakers wrote it into the Food and Drug Omnibus Reform Act (FDORA).
With a PCCP, a company can “telescope the review of a product,” said Jeff Shapiro, a Partner for the Washington, DC-based law firm King & Spalding. Meanwhile, “the traditional cycle that is used for 510(k)s is, ‘We know we have a few modifications coming down the pipe for this device, but we’re not ready. We haven’t validated the changes, so we’re going to leave them out of the 510(k) and we’re going to get our clearance, and then we’re going to come back to the FDA with a second 510(k) submission.’”
At best, Shapiro said, the agency will consider the second submission to be a Special 510(k) that carries a review time of 90 days. But most manufacturers won’t see a brisk, three-month turnaround when it comes to reviews because their 510(k)s aren’t deemed “special.”
Further, the FDA is becoming more discriminating when doling out the “special” review status. “More and more, the agency isn’t allowing that. The FDA has a pretty strict criteria now, stricter than I think was originally planned with the Special 510(k) Program when it started a few years ago,” Shapiro said in an interview.
For a Traditional 510(k), a manufacturer might need a Pre-Submission or two that could add even more time to when a product can launch. All of this means “there’s a there’s a delay in product innovation while we get that second 510(k),” Shapiro said. “If you step back and look at the big picture, PCCP is allowing that process to be telescoped and condensed, allowing companies to add to the first 510(k) a review of the modifications that are planned with an agreement on the validation data and the labeling.”
Shapiro added: “To me, that is novel. There is no other review process like that right now. The industry is going to save a lot of government review time that delays market entry and a new iteration of a device.”
The FDA makes clear in its draft guidance that a Predetermined Change Control Plan can be submitted for any type of medical device, but he says PCCPs make most sense for products that include software and/or use artificial intelligence (AI) and machine learning (ML).
“As a practical matter, this isn’t going to benefit every type of device for every manufacturer,” Shapiro said. “But PCCP is not just for software – there are a lot of hardware devices out there that are being iteratively improved.”
Software Expert: ‘Foolish’ for AI/ML Device Firms to Not Consider a PCCP
An August 2024 count showed that roughly 35 manufacturers had received PCCP authorization from the FDA since 2020. Enzyme CEO Jared Seehafer, whose company makes quality management system (QMS) software, worked with two of those successful device makers to develop their PCCPs and submit them to the agency.
“If you’re making an AI/ML product, it would be foolish not to try for PCCP approval and submit a plan to the FDA. Now, will you get everything you want? Probably not,” Seehafer said. But with its draft guidance, “I do think the agency is putting a stake in the ground and saying, ‘This is how we intend to allow you to evolve and innovate these products more rapidly than what would be traditionally allowed via the 510(k) process.’”
He further recommends that AI/ML device manufacturers should “get in the habit” of drafting PCCPs “regardless of whether a modification ends up as part of the final commercialized device. I predict that every company in the AI/ML space is going to need to start making these plans.”
Alex Cadotte, who reviewed products for the FDA and was a point person for software and digital health issues while at the agency from 2015 to 2021, warned in an interview, however, that “the level of scrutiny that the FDA review staff puts on AI and machine learning is so high that the amount of effort that you have to put in for a PCCP is sometimes almost as burdensome as submitting a second 510(k).”
That’s because the FDA “keeps upping the bar on regulation for AI and machine learning,” said Cadotte, who is now VP of Digital Health, AI, and Radiology Regulatory Affairs for medical device and diagnostics consulting firm MCRA (an IQVIA business). (Related: “Ex-FDA Reviewer On PCCP Policy: ‘Child of Pre-Cert’ Evolves Into ‘No Surprise’ Tool for Makers of Changing MedTech” – Enzyme, Oct. 15, 2024.)
“If a company is interested in making a PCCP for its AI and machine learning components, they should consider the value, if they haven’t thought about it, because they might not want to pursue a PCCP after they understand how much effort is involved and required,” he said.
PCCP and FDA’s Total Product Life Cycle Approach
Meanwhile, Enzyme’s Seehafer noted that PCCP as an FDA initiative will likely have long legs because it neatly fits under the agency’s Total Product Life Cycle (TPLC) umbrella. The FDA has been pushing the TPLC approach – which the agency says “promotes and enhances the transparency, efficiency, and agility” of its regulatory oversight – for several years now. Such an approach depends heavily on communication between the agency and device makers from a product’s birth to its grave.
As a part of TPLC, a Predetermined Change Control Plan allows a manufacturer and the FDA to engage in a more dynamic way, Seehafer said. “Sure, through a PCCP a company is making commitments that the agency isn’t necessarily going to see at the time the plan is submitted, but FDA will be able to ask about it the next time there’s a pre-market review. That kind of activity becomes much more of an ongoing interaction with the agency, as opposed to discrete pre-market reviews and post-market inspections. So I definitely believe that PCCP is here to stay and will evolve because it’s kind of pushing the boundaries a little bit.”
As for time to market, Seehafer agrees with Shapiro that manufacturers with approved PCCPs will save time and, quite likely, money. But he also says the FDA will save time because device modifications will be approved in advance, freeing up reviewers to scrutinize novel products.
“Certainly the intent – and I hope that the reality matches the intent as more and more time goes on – is to get the FDA to effectively sign off on validation activities companies could do without the FDA’s oversight that would allow them to further expand the performance of their products without needing a whole new 510(k) cycle,” Seehafer summed up. “I’m excited to see where PCCP goes.”
