Convergence: Tips for when to include PCCPs in product submissions

MONTREAL – The US Food and Drug Administration (FDA) sees predetermined change control plans (PCCPs) as a way to improve medical device innovation in the country, according to a speaker at RAPS Convergence 2023.

PCCPs are a way for medical devices to change post-marketing authorization without the need for a supplemental application, provided the changes are prespecified in the plan, Hrishikesh Gadagkar, senior principal at RQM+, said at the meeting.

Currently, the agency’s draft guidance for AI/ML devices is the only guidance available on PCCPs. It is worth reviewing even if you don’t have software in your submission, Nancy Morrison, vice president, intelligence and innovation, at RQM+, told attendees (RELATED: FDA draft guidance allows AI/ML devices to evolve without requiring new submissions, Regulatory Focus 31 March 2023).

The agency is looking for engagement from sponsors on their plans surrounding PCCPs and about future submissions, and the Q-Submission process is a method for receiving FDA feedback before a marketing submission. However, PCCPs are not permitted in pre-submissions even though manufacturers can discuss their plans through the pre-submission process, Gadagkar noted (RELATED: FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance, Regulatory Focus 06 June 2023).

“[T]his is essentially the messaging that even the FDA is trying to put it out for everyone's benefit,” he said.

Experience with PCCPs

Although PCCPs are relatively new, there are already some lessons that can be learned from engagement with the agency. “Sometimes you win, and sometimes you learn,” Morrison said.

A “perfect example” of using a PCCP would be in a 510(k) submission where plan changes to a piece of software include “changing the threshold, retraining the algorithm on data labeled and pre training the algorithm,” she said.

Morrison said FDA will ask in nearly every software PCCP about a manufacturer’s plan to release the software -- whether the software updates automatically or is a “discrete issuance of the new algorithm.”

“Either answer is okay, but just know that you're going to have to have that answer in your PCCP as you go,” she said.

However, a PCCP for a more complex algorithm submitted through the De Novo process, where clinical testing is needed to assess pre-determined outcomes, is where manufacturers may run into issues, Morrison said. For instance, when data changes, customers have feedback on the product, or healthcare providers use the product in unexpected ways, sponsors will likely need to file another submission.

“If you change it, that’s not a letter to file, that's going back to the agency in another submission, and you have to get that approval for that changed PCCP through another submission,” she said.

There are some situations where a PCCP may not be appropriate, such as in the case of a complex Class III combination product where the changes needed may fit into a special 510(k) submission, rather than updating changes to a PCCP. While a PCCP is possible in this situation, FDA “strongly discouraged” a manufacturer from going that route in the pre-submission meeting, Morrison said, noting that the review process would be more complex and that including a PCCP could add to the review time.

“I think the lesson I take away from that is just because you can do a PCCP doesn't mean that you should,” she said. “Sometimes preserving that relationship with the reviewer, sometimes making their job easier, makes your job easier.”

Attendees interested in using PCCPs in their submissions should also know it’s important to address device performance testing separately from PCCPs, and that it is important to separate out issues with the PCCPs from other issues. Additionally, things that may not have been possible prior to the Food and Drug Omnibus Reform Act (FDORA) passing may be true now, Morrison explained.

Above all, there is currently “very little risk” to including a PCCP in a 510(k) submission because the PCCP can be withdrawn at 60 days. “If you feel like you have a pretty good submission and this might be just a little bit of a pressure point, then I would say go for it,” she said.

Convergence: Tips for when to include PCCPs in product submissions

Related topics

Recommended content

Welcome to the new RAPS Digital Experience