Expert: ‘One does not just walk into Mordor and get a PCCP’

Cincinnati, OH – While there is a lot of excitement around the use of predetermined change control plans (PCCP), medtech sponsors should consider whether the added administrative cost warrants including it in a premarket application to the US Food and Drug Administration (FDA), according to industry experts.

The PCCP submission should also be considered separate from the overall premarket application so that if it is denied, it doesn’t jeopardize the rest of the submission, they advised at the 2023 AI Summit held by the AFDO/RAPS Healthcare Products Collaborative.

Cassie Scherer, senior director for global digital health policy at Medtronic, said she is a big fan of using PCCP because it is the first such tool that allows at least some AI/ML-enabled devices to rapidly update themselves without requiring a new premarket application. However, she cautioned that it may not be the solution for all AI/ML products, and PCCP still has a lot of evolving to do as the medtech industry and FDA gain more experience with it.

Scherer said that sponsors need to realize that a PCCP submission in a premarket application requires the same level of work as what is required in a postmarket submission. She also noted that they need to sit down with their research and development team to discuss what a product may look like two or three generations after it has been allowed on the market, such as how the product’s sensitivity and specificity may improve or what additional inputs it may be able to account for, before they decide to use a PCCP.

“As you are looking to develop your premarket submission, you’re not only doing that submission, but you’re also sort of coupling with it your second- and third-generation submissions as well,” Scherer said. “It’s a lot of work upfront.”

“For those of us who just want it on the market quick and may not be thinking already about how we’re going to be modifying this in second and third generation, it just doesn’t make sense,” she said. “There’s no way that you’re going to get this level of detail.”

Scherer said that ultimately, the time and effort that sponsors put into the PCCP part of the premarket application may not make sense if they are just thinking of making limited updates in the future. In such situations, it may be better for sponsors to take the traditional route and submit a new premarket application when a product needs to be updated.

Alex Cadotte, senior director for digital health at MCRA, echoed that advice. He said he has conversations with clients where he asks them whether it makes sense to go through the PCCP process based on their plans for the product.

“The question often is whether the juice is worth the squeeze,” he said during the panel discussion. “What is this going to gain you, is this going to keep you from doing one 510(k)?… It may be easier for you to do the one 510(k) than to do the PCCP.”

“One does not just walk into Mordor and get a PCCP,” he added.

Besides having early internal conversations between the R&D and regulatory officers, sponsors should also take full advantage of FDA’s presubmission process to talk with the agency about whether it makes sense to include PCCP in the premarket application, according to Scherer.

“It’s also important to have your PCCP separate from your submission, meaning that they’re not intertwined so that as you’re going through your submission process, if it looks like your PCCP might be holding up the submission, you can drop it, and it’s not going to impact your submission,” she said. “You don’t need the PCCP to get clearance or approval. It’s just a helpful mechanism tool for you for your postmarket status.”

FDA has allowed several products with PCCP to enter the market since 2019, allowing them to be updated within parameters agreed upon between the sponsor and the agency without the need for a new premarket submission. However, the authority to allow such products on the market was formally entrusted to FDA by Congress in the 2022 Food and Drug Omnibus Reform Act (FDORA). FDA has stated that PCCPs go beyond AI/ML products, and while it is still developing guidance on the topic, it urges sponsors to discuss the issue with regulators so they can figure out the limits of PCCP (RELATED: Figuring out the limits of predetermined change control plans, harmonizing regulations, Regulatory Focus 19 October 2023).

MiRa Jacobs, acting assistant director for Digital Health Policy at the Digital Health Center of Excellence at FDA, noted during the panel discussion that any change to a PCCP will require a new marketing submission since the PCCP included in the original marketing submission of the device was established as part of the authorization.

Expert: ‘One does not just walk into Mordor and get a PCCP’

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