FDA issues much-anticipated PCCP draft guidance

The US Food and Drug Administration (FDA) has issued a draft guidance detailing what modifications the agency considers appropriate for pre-determined change control plans (PCCPs), and what information sponsors should include in their premarket approval (PMA), de novo, or 510(k) submissions to support the acceptance of their proposed PCCP.

Typically, if a manufacturer wants to make certain changes to a marketed product, they need to submit a supplement or new submission detailing those changes for the FDA to review. However, there are certain situations where the agency has agreed to allow sponsors to make changes to their product without the need to file a supplement or new submission, if the changes have been predetermined between regulators and the company.

Under the 2022 Food and Drug Omnibus Reform Act (FDORA), FDA was given explicit authority from Congress to allow sponsors to submit PCCPs in their premarket submissions. The draft guidance published on 21 August, elaborates on how the agency will treat PCCPs moving forward.

“For purposes of this guidance, a PCCP includes those device modifications that generally would otherwise require a new marketing submission,” said FDA. “These modifications include those that could significantly affect, or that otherwise affect, the safety or effectiveness of the device, unless an authorized PCCP covers those modifications.”

“By including a PCCP in a marketing submission for a device, manufacturers can prospectively specify and seek premarket authorization for intended modifications to a device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing such modifications – provided the changes are implemented consistent with the PCCP that has been reviewed and established through a device marketing authorization (referred to hereafter as the ‘authorized PCCP’),” the agency added. “In other words, obtaining FDA authorization of a PCCP as part of a marketing submission for a device allows a manufacturer to modify its device over time in accordance with the PCCP instead of obtaining separate FDA authorization for each significant change prior to each implementation.”

FDA noted that the guidance does not cover change plans that don’t require a new premarket submission, and sponsors should instead document such changes in the device master record file as outlined in the quality system regulation (QSR). Also, the agency clarified that the guidance only applies to the device component of a device-led combination product PMA or 510(k) submission.

PCCP is still a new concept, and FDA officials have said they are still figuring out the limits of the changes they can allow in a premarket submission. The agency said if sponsors know they will make changes to their product in the future that may be allowed under a PCCP, they should talk to regulators early to figure out what is allowable together.

“FDA highly encourages early engagement regarding a proposed PCCP with the FDA review division; in particular, early engagement could be especially helpful for certain devices, including combination products and high-risk, life-sustaining, life-supporting, or implantable devices,” said FDA. “FDA encourages manufacturers to leverage the Q-Submission Program for obtaining FDA feedback on a proposed PCCP for a device prior to submitting a marketing submission.”

FDA also listed some guiding principles that sponsors should consider when trying to figure out if their product change qualifies for a PCCP. They include maintaining a reasonable assurance of safety and effectiveness, whether the PCCP is the least burdensome way to allow device modifications, whether the proposed changes are part of the device's marketing authorization, are the proposed changes specific enough, and do they agree with the agency's existing device modification guidances.

The guidance includes sections detailing what kinds of changes are appropriate to include in a PMA, de novo or 510(k) submission. FDA said that changes that maintain or improve the safety or efficacy of the product could qualify for a PCCP, but they should be specific, verifiable and validated.

“Modifications included in a PCCP must maintain the device within the device’s intended use, and as applicable, must allow the device to remain substantially equivalent to the predicate device,” said FDA. “In general, FDA believes that modifications included in a PCCP should also maintain the device within the device’s indications for use.”

“Recognizing there is a spectrum of risk for devices, for purposes of reviewing a PCCP, FDA intends to, among other considerations, take into account the Guiding Principles recommended in this guidance (Section IV.), the benefit-risk profile of the specific device that is the subject of the PCCP, the specific modifications being proposed, and FDA’s experience applying this policy across different device types,” the agency added. “As such, certain modifications that may be appropriate for inclusion in a PCCP for one device may not be appropriate for inclusion in a PCCP for another device.”

The guidance includes several decision trees and examples of changes that may or may not be appropriate for a PCCP.

Stakeholders can comment on the draft guidance on www.regualtions.gov under docket no. FDA-2024-D-2338 until 20 November.

Draft guidance

FDA issues much-anticipated PCCP draft guidance

Related topics

Recommended content

Welcome to the new RAPS Digital Experience