PCCPs: Sponsors should engage early, ensure they need the change, be specific
SAN DIEGO – A top US Food and Drug Administration (FDA) official recommends that sponsors who want to include predetermined change control plans (PCCP) with their premarket submissions should engage the agency early. She also said that sponsors should only include PCCPs for changes that require a new submission and provide enough detail so that reviewers can feel confident in the safety and efficacy of the changes.Jessica Paulsen, acting deputy director at FDA Digital Health Center of Excellence (DHCoE), discussed the agency’s experience with applications that include PCCPs virtually during a panel at the 2025 Medtech Conference. One issue she says the agency has seen is sponsors submitting PCCPs for changes that don’t require a new submission.
“Please do remember to keep in mind FDA's existing modification policies,” said Paulsen. “We continue to see companies periodically propose PCCPs for changes that otherwise do not require submission to FDA. Those are not the right types of changes to be thinking about here. We only want to see changes to PCCPs that would actually need to be submitted to FDA.”
While she has repeatedly advised sponsors to meet with FDA early on, Paulsen again emphasized that early discussions with the agency are very important for all involved.
“[Q-Submissions] are proving to be a great way to get early feedback from FDA on a proposed PCCP, which can really help set you up for success when your rubber meets the road in your marketing submission,” said Paulsen. “Early engagement is particularly helpful for companies that have not previously submitted a PCCP.
“Overall, I think it's going to change over time, but I would just highly encourage anyone considering indication changes in particular, reach out to FDA, talk about it early, maybe informally or in a [pre-submission meeting] if it's a more baked proposal,” she added “I think it's good to get that early feedback to see if you're walking down a path that's pretty viable in a PCCP.”
Paulsen also asked sponsors to be specific in their PCCP proposals.
“Sometimes we see companies propose more high-level exploratory types of changes, which can be really difficult for our teams to evaluate,” said Paulsen. “We encourage you to be very deliberate and identify the specific modifications that you intend to make to your device and provide them in enough detail so that the reviewers can really reach that conclusion that the device is going to remain safe and effective as they're considering those modifications.
“The higher the quality submission you can prepare with the right level of detail, I think will help you be most successful and minimize some of those deficiencies,” she added.
The volume of submissions with PCCPs has been growing, which has led everyone involved to become more comfortable and familiar with the concept, Paulsen said, adding that the process will need to evolve based on the experience.
She noted that modifications to a device's indication for use would be difficult to prospectively assess in a PCCP and ensure the product remains safe and effective. However, she said some such modifications may be appropriate.
“We've seen a handful, at least, that have gone through and been authorized, things like specifying use of a device with an additional compatible device or component or, adding a human genetic variant,” Paulsen said. “There have been specific cases where it made sense for that device, and we've been able to review the proposed PCCP and come to the conclusion that the device would be safe and effective if it had changed based on the information provided.
Yarmela Pavlovic, chief regulatory officer at Medtronic and panel moderator, echoed Paulsen’s comments that sponsors should only use PCCPs for changes that require FDA submission.
“Predetermined change control plans are only suited for circumstances where the change would otherwise require new submissions,” she said. “We're really talking about the subset of changes that would otherwise require a submission to the regulator and it's really about reducing the number of reviews and making the products available more rapidly for driving patient value globally.
“PCCPs are not a panacea for everything,” she added. “There are types of changes for which this approach is not the right approach.”
Pavlovic advised sponsors to familiarize themselves with their product roadmap and the appropriate approach to testing and validation well in advance, and to be able to document everything.
“It doesn't reduce the work that needs to be done, it just shifts when it happens in the overall life cycle,” she added.
Nate Brown, a partner at Akin Gump Strauss Hauer & Feld, said that in some cases, it may be worth it for sponsors to be bolder, more creative, and less specific in their PCCP submission.
“You really need to think sort of five or more years down the road and really sort of decide…If it's really creative, am I going to need two pre-sub cycles and am I going to get it either authorized on its own or am I going to kind of hold back my principal submission to add that to it?” Brown said. “If it's worth it, then go all the way in and have the discussion and be specific… But just recognize if it's not something where it's a pretty clear path, you need to be really recognizing that and make sure you know what you're getting out of the process.”
Other regulators are looking at FDA’s work on PCCPs. The International Medical Device Regulators Forum (IMDRF) agreed to a new draft document on PCCPs, which Paulsen noted has been shared with its members for feedback by 8 December (RELATED: IMDRF plans new PCCP guideline, adds new affiliates, Regulatory Focus, 30 September 2025).
“I want to give a significant shout-out to the FDA for really being the originators of this concept,” said Pavlovic. “This is truly an FDA innovation, and it has been carried forward from there.”
Martin Witte, senior director for growth drivers at TÜV SÜD, echoed those sentiments.
“I actually value what the FDA has put out in the last couple of decades about innovative approaches towards changes,” he said. “To be honest, I'm always looking on the other side of the ocean and seeing what I can copy, maybe as the business model, to offer services that can make things better, while being compliant to EU [Medical Device Regulation (MDR)].”
Witte noted that PCCPs may be considered only in the context of the EU’s recently enacted Artificial Intelligence (AI) Act. While notified bodies are not allowed to advise manufacturers about their applications, he advised sponsors to use the structured dialogue process to clarify their regulatory pathway.
Witte also said that he’s been involved in conversations at the European Commission to consider PCCPs as part of the MDR and In Vitro Diagnostics Regulation (IVDR).
