FDA issued a draft guidance on August 22 detailing the types of modifications it considers suitable for inclusion in a Predetermined Change Control Plan (PCCP) and the information sponsors should include in their premarket approval (PMA), de novo, or 510(k) submissions to support their proposed PCCP.
Supplemental Documents May Not be Required
Typically, if manufacturers wish to make certain changes to an already marketed product, they need to submit supplemental or new documentation outlining those changes for FDA review. However, in certain cases, where changes have been predetermined between the regulatory agency and the company, the FDA agrees to allow sponsors to make changes to their product without submitting supplemental or new documentation.
Under the 2022 Food and Drug Omnibus Reform Act (FDORA), Congress explicitly authorized the FDA to allow sponsors to include a PCCP in their premarket submissions. The draft guidance released on August 21 outlines how the agency intends to handle PCCPs going forward.
The FDA stated: “For the purposes of this guidance, a PCCP includes device modifications that would typically require a new premarket submission. These modifications include those that may significantly impact or otherwise affect the device’s safety or effectiveness, unless covered by an authorized PCCP.”
“By including a PCCP in the device’s marketing submission, manufacturers can predefine and seek premarket authorization for anticipated modifications to the device without needing to submit additional marketing applications or obtain further FDA authorization before implementing such modifications—provided the changes are consistent with the authorized PCCP reviewed and approved as part of the device marketing authorization (hereafter ‘authorized PCCP’),” the agency added. “In other words, obtaining FDA authorization for a PCCP as part of a device marketing submission allows manufacturers to modify their devices per the PCCP, rather than seeking separate FDA authorization for each significant change before implementation.”
The FDA noted that the guidance does not cover change plans that do not require a new premarket submission, and sponsors should document such changes in the device master record as outlined in the Quality System Regulation (QSR). Additionally, the agency clarified that this guidance applies only to device-led combination products and device components submitted under PMA or 510(k).
What PCCP Changes Are Allowed?
PCCP remains a new concept, and FDA officials stated that they are still researching the limits of changes allowed under premarket submissions. The agency indicated that if sponsors know they will make changes to their products that may be allowed under a PCCP, they should communicate with the regulatory agency early to determine which changes are permissible.
“The FDA strongly encourages early discussions with FDA review divisions regarding proposed PCCPs; early discussions are particularly beneficial for certain devices, including combination products and high-risk, life-sustaining, life-supporting, or implantable devices,” the FDA stated. “The FDA encourages manufacturers to use the Q-Submission Program before submitting marketing applications to obtain FDA feedback on the proposed PCCP for the device.” The FDA also outlined several guiding principles that sponsors should consider when determining whether their product changes qualify for PCCP eligibility. These include maintaining a reasonable assurance of safety and effectiveness, ensuring that the PCCP is the least burdensome approach for device modifications, determining whether the proposed changes are part of the device’s marketing authorization, whether the proposed changes are sufficiently specific, and whether they align with existing FDA device modification guidance.
The guidance includes details on what types of changes are suitable for inclusion in PMA, de novo, or 510(k) submissions. The FDA indicated that modifications that maintain or improve product safety or effectiveness may qualify for PCCP, but such changes must be specific, verifiable, and validated. The FDA stated: “Modifications included in the PCCP must keep the device within its intended use and, if applicable, must maintain the device as substantially equivalent to the predicate device. Generally, the FDA considers modifications included in the PCCP should also keep the device within the scope of the device’s indications for use.”
“Recognizing the range of risks associated with devices, for the review of PCCPs, the FDA intends to consider the guiding principles recommended in this guidance (Section IV), the benefit-risk profile of the specific device subject to the PCCP, the specific proposed modifications, and the FDA’s experience in applying this policy across different device types,” the agency added. “Therefore, certain modifications may be appropriate for inclusion in one device’s PCCP but may not be suitable for inclusion in another device’s PCCP.”
The guidance includes several decision trees and examples of changes that are suitable or unsuitable for PCCPs. For more information, email info@accelgroups.com.
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