Figuring out the limits of predetermined change control plans, harmonizing regulations

ANAHEIM, CA – While the US Congress has given the Food and Drug Administration a lot of leeway in terms of how it allows products with predetermined change control plans (PCCP) on the market, a top official says there are certain products that likely won’t qualify for such protocols.

A panel of experts recently came together at the 2023 MedTech Conference to discuss how FDA plans on allowing PCCP-based products on the market under new authority given to the agency in the 2022 Food and Drug Omnibus Reform Act (FDORA). While the agency allowed several products with PCCP to enter the market even before the law was passed, Angela Krueger, deputy director for regulatory policy at the Center for Devices and Radiological Health (CDRH), noted that the law gave regulators a better understanding of the “rules of the game.”

Krueger, whose job is to interpret laws that apply to FDA at the Office of Product Evaluation and Quality (OPEQ), said the agency has been busy the past 10 months reviewing the PCCP provisions of FDORA and figuring out its limitations.

“When you look at the legislation, the rules of the game are pretty broad,” Krueger said. “There’s not a ton that's out of bounds.”

Broad authority

While PCCPs initially were considered for products with artificial intelligence/machine learning (AI/ML) capabilities, Krueger noted that FDORA gives FDA authority to allow a much broader array of medtech products with such protocols on the market. FDORA allows products with PCCPs on the market under the premarket approval (PMA) and 510(K) clearance pathways as long as the respective products remain substantially equivalent to their predicate product, and remain safe and effective, she said (RELATED: Stakeholders seek clarity, risk-based approach in AI/ML PCCP guidance, Regulatory Focus, 10 July 2023).

“When we see PCCPs in submissions, it gives us an opportunity, from a review perspective, not to just look at what’s in front of us, but to think beyond and to think about the life cycle of a product, even outside of the software space,” Krueger said.

While the law doesn’t put many limits on FDA’s ability to allow PCCP products on the market, Krueger said it is still important to think ahead about where certain PCCP products may end up in the future and consider their market-worthiness accordingly. For instance, she noted that single-use products that become reusable devices may cross the regulatory line for PCCP, as would products that may change indications from prescription use to over-the-counter use.

“When I think about those types of things that really don't fit within a PCCP, they’re generally places where we’re seeing new or different risks that would be introduced to the use of the device in that context,” Krueger said. “Sometimes, thinking about it from a risk perspective and thinking about, ‘Is this risk mitigation the same as, or similar to, what I’ve defined for my device space?’ is something that might be a general rule of thumb that you could start with.”

PCCP may not be appropriate when there are new or additional risks, she said.

Krueger said it may be helpful for sponsors to talk to FDA early, especially if they think their PCCP is getting close to the regulatory threshold where they may not be able to implement the protocol. She said they may be able to address issues such as when a product’s PCCP doesn’t meet FDA’s substantial equivalence requirements or reasonable assurance of safety and effectiveness, that even the agency hasn’t considered. Starting an early conversation could allow sponsors to work with regulators to figure out if there is a way to implement a PCCP within the legal limitations.

“As it relates to indications for use, I think there are appropriate situations where the agency might want to think about whether that works well with the company, and so I would certainly encourage for indication-specific PCCPs, talking to the agency first,” Krueger said. “I think we are treading cautiously there, but I also think that what we know when it tips over the line to something that would go into the new intended use space.”

When deciding what makes sense in terms of the indication of a PCCP product, Krueger said the eligibility may be device-specific.

Sonja Fulmer, deputy director at the FDA’s Digital Health Center of Excellence, said sponsors are also not beholden to implementing a PCCP if they decide to change the protocol. She noted they can come back to FDA and ask to change the protocol based on a new product submission.

“This isn’t like a road map that you’re committed to,” she said. “It’s something that you’re hoping to pursue, but it’s not set in stone.”

Harmonization

Bradford Spring, global head of regulatory policy at Roche Diagnostics, said FDA’s AI/ML guidance on PCCP is a “great first step” but he and others in the medtech industry are also looking to other global regulators to see how they develop similar PCCP frameworks to address digital health, and specifically AI/ML products with PCCP.

“What we’re doing at Roche and other companies too, through AdvaMed, is looking to see how can we harmonize the approach,” he said. “The last thing we want is 10 different countries coming up with 10 different types of PCCPs because then we’re just duplicating the work or we just have inconsistencies around the world.”

Spring noted that Japan has instituted a PCCP framework that is similar to the US and regulators in the UK, Canada, Taiwan and Singapore have shown interest in following suit.

Jeff Ballyns, a director for regulatory strategy at Becton Dickenson, echoed the sentiment, stating that while they are thankful that PCCP was expanded to products beyond software and medical devices, it is important that regulators harmonize the framework.

“We don’t want PCCP to be a paradigm that is unique just to the US,” he said. “We’d really like to see it adopted in other regions across the world.”

Figuring out the limits of predetermined change control plans, harmonizing regulations

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