SVP Global Regulatory and Quality
A new PCCP draft guidance outlines what elements the agency expects in these plans
As published in Today’s Clinical Lab
The U.S. Food and Drug Administration (FDA) recently issued a second draft guidance on predetermined change control plans (PCCPs) for medical devices that could influence how clinical labs modify laboratory-developed tests (LDTs).
PCCPs are documents included in a marketing submission that:
- Describe anticipated changes to the FDA-approved or -cleared medical device;
- Detail how these changes will be implemented and validated.
If approved, these plans allow changes without necessitating a new FDA submission, potentially accelerating a device’s modification and saving FDA review time.
Relevant to devices—including in vitro diagnostic devices (IVDs) and device-led combination products that are reviewed through the 510(k), De Novo, and pre-market approval pathways—the FDA guidance proposes a policy for PCCPs and provides recommendations on the information to include in a PCCP.
The guidance may be of interest to the clinical laboratory community, as PCCPs may offer a way to introduce flexibility for modifying certain LDTs under the FDA’s recently issued final rule on regulating these assays.
Elements of a predetermined change control plan
A PCCP should consist of:
- Description of modifications, which outline the specific, planned changes that may be made to the device, including the specifications for the characteristics and performance of the planned modifications.
- Modification protocol, which describes verification and validation activities, including predefined acceptance criteria, that will support each modification to ensure the device remains safe and effective (or substantially equivalent) across the intended use populations.
- Impact assessment, which identifies the benefits and risks introduced by the specified, planned modifications and addresses how the verification and validation activities of the modification protocol will continue to ensure the safety and effectiveness (or substantial equivalence) of the device.
Here are the key takeaways about the FDA’s guidance on PCCPs:
- Scope: Unlike the FDA’s April 2023 draft guidance that focused on AI- and machine-learning-enabled devices, the new draft clarifies that PCCPs apply broadly, not just to these technologies.
- Purpose: The goal of a PCCP is to provide a least burdensome option for manufacturers to implement device modifications without needing to submit a new marketing submission for each modification—all while maintaining a reasonable assurance of safety and effectiveness (or substantial equivalence).
- Specificity: The modifications included in a PCCP must maintain the device within its intended use and should include specific changes that can be verified and validated.
- Authorization: To gain authorization, a PCCP must provide enough detail to allow the FDA to assess the reasonable assurance of safety and effectiveness (or substantial equivalence).
- Implementation: A PCCP is part of the device’s marketing authorization; therefore, the manufacturer is required to implement modifications consistent with their authorized PCCP.
In general, the FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance describes the agency’s current thinking on a topic and should be viewed as recommendations. The updated draft guidance on PCCPs is open for public comment for 90 days following its official issuance on August 22, 2024.
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