By Shawn M. Schmitt
Communications Specialist, Enzyme
A former US Food and Drug Administration official who contributed to the FDA’s draft guidance shaping the agency’s thinking on Predetermined Change Control Plans for medical devices is bullish on PCCP’s ability to get updated products to patients faster – and believes it’s a win-win for manufacturers and FDA reviewers alike.
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, also said PCCP was the next logical step for the FDA’s now-completed Software Precertification Pilot Program. Pre-Cert, the use of which was rare by device firms, fizzled out after its pilot culminated in a wide-ranging September 2022 report from the agency.
“I did a detail with [the FDA’s Digital Health Center of Excellence (DHCOE)] for a year where I worked on the Pre-Cert program,” Cadotte said in an interview. “To me, PCCP was always a child of Pre-Cert. PCCP has a lot of similar ideas that I believe is the byproduct of what the FDA learned from Pre-Cert.”
The FDA’s five-year Pre-Cert pilot, limited to trusted manufacturers of high-quality software as a medical device (SaMD), was an experiment designed to better align the structure of the agency’s pre-market regulatory oversight with the rapid product development cadence of SaMD relative to traditional hardware medical devices. The FDA would focus less on the pre-market review of every new software product and more on oversight of the company’s overall practices and procedures. Companies that received this “pre-certification” would benefit from streamlined agency review of low- to moderate-risk software releases.
Meanwhile, Predetermined Change Control Plans came on the scene a few years before Pre-Cert began to fade away. PCCP was later given the blessing of Congress in 2022 when lawmakers made clear in the Food and Drug Omnibus Reform Act (FDORA) that the FDA could approve and accept PCCPs for any device type. A PCCP is documentation that is part of a company’s product 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approval (PMA) supplement isn’t needed for a product every time an update is needed, the agency says in its August 2024 draft guidance document on the topic.
While PCCPs can be submitted to the FDA for any type of medical device, such a plan appears to make most sense for products that include software and/or use artificial intelligence (AI) and machine learning (ML). For example, cardiac devices, surgical robots, and diagnostic imaging devices all fit that bill – just to name a few device types that would appear on a never-ending list of such products.
“When I read the guidance and how the FDA interpreted the statute, I thought, ‘Wow, this is a gamechanger,” said Jeff Shapiro, a Partner for Washington, DC-based law firm King & Spalding. “This is not just focused on AI and software. This is every device that FDA regulates.”
The FDA’s draft guidance advises that a PCCP “describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications” – among a slew of other recommendations.
“The FDA made it clear in the draft guidance that it doesn’t want a company’s wish list of modifications to be part of a filing. Rather, it has to be product modifications,” Shapiro said in an interview. Such modifications, he said, would cover a short time frame. “When you thought through how you’re going to validate it, how it’s going to be labeled – whatever needs to be done for the modification – then it’s probably going to be a few months away, or maybe six months away, or maybe a year. It’s sort of near term and something that you know for sure you’re going to implement. Again, it can’t be a wish list.”
‘Pre-Cert Is Not Dead – It Evolved’
When it comes to Pre-Cert, it’s “still an interesting idea, but probably the most likely practical implementation that you’re going to see is PCCP,” former FDAer Cadotte said. “The whole idea behind Pre-Cert was that you would get pre-certified to have kind of a lower level of regulation, because all of your processes and procedures were adequate, with the general idea being that a company would gain access to the FDA submission review fast lane if they were Pre-Cert.”
He further explained: “PCCP is kind of a similar idea, except it’s a bit more focused on whatever topic the manufacturer wants to talk about, or to basically get permission from the FDA make a modification after product submission. These are supposed to be items that you normally can’t modify without coming back to the FDA. The whole idea is similar in the sense that a manufacturer would lay out all their procedures and processes. They’d also put together a protocol and predefine everything they would be doing so there are no surprises for the FDA. And in return the agency would essentially pre-certify that it’s just a predetermined change instead of something that needs pre-certification.”
Cadotte, who is now VP of Digital Health, AI, and Radiology Regulatory Affairs for medical device and diagnostics consulting firm MCRA (an IQVIA business), said there probably wouldn’t be a PCCP initiative at the FDA had Pre-Cert not paved the way.
“I was in the meeting when [former DHCOE Director Bakul Patel] introduced the idea of PCCP to the team, and the team that was working on this was the same people he had worked with on Pre-Cert,” Cadotte said. “I was one of the team leads for one of the workstreams for Pre-Cert, and a lot of what I had worked on there seemed to influence a lot of what eventually became PCCP. From my perspective, Pre-Cert is not dead – it evolved. PCCP is the legacy from Pre-Cert.”
Do FDA Policy Wonks, Product Reviewers Agree on PCCP?
When the FDA’s draft guidance on Predetermined Change Control Plans was released in August, it was determined at that time that roughly 35 manufacturers had received PCCP authorization from the agency since 2020, according to a count by Brendan O’Leary, a former Deputy Director of the FDA’s DHCOE who became a digital health consultant in 2023.
Despite the thus-far anemic number of PCCP authorizations, King &Spalding’s Shapiro said he’s confident that PCCP is here to stay and won’t disappear because of any potential industry apathy. (Sure, PCCP is enshrined in 2022’s FDORA, but there’s a graveyard full of FDA initiatives and programs that, despite being written into law, went nowhere and faded into obscurity – so it’s always a flip of the coin.)
Shapiro admits he has an outside-FDA view, but by speaking with experts familiar with the agency’s thinking, he says PCCP is a policy that isn’t exciting only the policy wonks within the FDA, but also has buy-in from most of the agency’s product reviewers. “Some reviewers in review teams have gained experience with PCCP due to the software angle,” he noted.
The FDA’s draft guidance “reads like the FDA and its reviewers have had experience when it comes to PCCPs, and they took those lessons learned and put them in the guidance,” Shapiro said. Further, “the guidance is so detailed and so specific that it feels not just like a policy push at the top – it feels more like something that will have traction in the ranks with the people who actually have to review these product submissions by manufacturers.”
Like MCRA’s Cadotte, Shapiro is bullish on PCCP, adding that it’s “going to be great for the industry and for potentially getting better devices into the hands of doctors and patients quicker.”
As for Cadotte, he said that during his time at the FDA that “review staff, for the most part, was in favor” of PCCPs. “But the thing is, when it comes to the review staff at agency, it’s a really large, diverse group of people. You may get different feedback from different teams for various reasons.”
He went on: “When writing a PCCP one should consider first and foremost that PCCPs should contain a highly detailed specific pre-specification of what you plan to do. Review staff may not always be comfortable with all the changes you want to make to the device being part of a PCCP. The good thing is that it’s not something that the FDA is just picking up as part of an unofficial policy anymore. It’s now part of the Food, Drug, and Cosmetic Act, and review staff is gaining more experience in reviewing them.”
