This Guidance focuses on Section 515 and provides FDA’s policy and recommendations for marketing submissions or PCCPs for all device types—not just those with AI/ML technology.

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.

This draft Guidance is another in an increasingly long line of FDA guidance and legislative efforts designed to implement the concept of PCCPs to allow device manufacturers to plan for and make changes to devices without requiring submission of new premarket notifications (510(k)) or premarket approval (PMA) supplements that would otherwise be required. This history is detailed in FDA’s new draft Guidance.

Most pertinent, however, is that the Food and Drug Omnibus Reform Act of 2022 amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to add Section 515C, which created a pathway for FDA to authorize PCCPs for devices that require PMA or 510(k).

In 2023, FDA issued a draft Guidance on PCCPs for devices specifically using machine learning (ML) or artificial intelligence-enabled software. This prior draft Guidance incorporated stakeholder feedback on an earlier discussion paper and proposed a policy to support iterative improvement of devices through prospective FDA review designed to maintain reasonable assurance of device safety and effectiveness. Duane Morris published a previous Alert on this Guidance shortly after its issuance.

FDA’s newest draft Guidance, issued a little over a year later, is broader than the guidance on AI/ML-enabled devices and provides recommendations for manufacturers to use PCCPs in any device type. This Guidance focuses on Section 515 and provides FDA’s policy and recommendations for marketing submissions or PCCPs for all device types—not just those with AI/ML technology. Specifically, the draft Guidance includes recommendations on the types of modifications that may be appropriate for inclusion in a PCCP and information that should be included in a PCCP in a marketing submission for all devices types.

Generally, to be approved, PCCPs should contain information sufficient for FDA to determine that the medical device, including future modifications, will remain safe and effective or substantially equivalent to a predicate device. PCCPs should include modifications that maintain or improve device safety or effectiveness and maintain a device within its intended use. Examples of generally appropriate modifications to include in a PCCP are changes to materials, sterilization using well-known methods or indications for in-home use.

FDA warns that modifications that introduce a new risk or major change to a device’s intended use may not be appropriate to include in a PCCP. Modifications inappropriate for a PCCP may include, for example, those that may require new clinical data, include a new patient population in labeling or remove contraindications. Manufacturers should perform risk assessments to determine proposed modifications’ risk and nature to assess whether such modifications are appropriate for inclusion in a PCCP.

FDA reiterates its recommendation, stated in previous draft Guidance, that PCCPs should:

• Describe intended, specific modifications;
• Outline methodology to develop, validate, implement modifications and maintain safety and effectiveness; and
• Assess the impact of modifications including risks, benefits and mitigation plans.

In the methodology section, or “modification protocol,” FDA proposes that manufacturers include update procedures and performance evaluation methods such as pre-defined acceptance criteria. Update procedures should reflect manufacturers’ monitoring of safety and effectiveness, and maintain transparency to users. For example, in the modification protocol, manufacturers should address any labeling updates and post-market surveillance plans.

Importantly, manufacturers should ultimately implement changes consistent with an authorized PCCP’s specified modifications and methodology protocol. FDA generally considers deviations from the authorized PCCP to render devices misbranded and adulterated. FDA acknowledges that manufacturers may have to amend previously approved PCCPs; however, FDA assumes that such amendments require a new marketing submission. FDA also notes that modifications must be in line with manufacturers’ quality systems and warns that PCCPs may be denied for not adhering to quality and safety methods.

FDA highly encourages early engagement with the FDA review division on proposed PCCPs, including use of the Q-Submission Program, to receive pre-submission feedback on proposed PCCPs. FDA will help a manufacturer early on to assess the scope of the modifications proposed and whether those modifications are appropriate for inclusion in a PCCP.

Overall, FDA followed five guiding principles in creating this Guidance, which manufacturers should keep in mind when creating and proposing PCCPs for FDA review:

1. Reasonable assurance of safety and effectiveness and substantial equivalence of devices with PCCPs. This principle recognizes that PCCPs are part of the device marketing authorization process through which FDA will assess the reasonable assurance of safety, effectiveness or substantial equivalence of a device.
2. PCCPs may be a least burdensome option to support device modification. This principle recognizes that PCCPs are optional and supposed to be designed to be least burdensome for manufacturers and FDA. Thus, FDA’s review of a device and its proposed PCCP follows a risk-based approach and FDA’s benefit-risk framework.
3. PCCPs are part of a device’s marketing authorization. This principle acknowledges that PCCPs, once approved, are included in the device’s letter of authorization and must be used by a manufacturer when it chooses to implement modifications.
4. PCCPs are specific. This principle cautions that PCCPs are not intended to be a list of any modification that a manufacture may possibly make in the future. The proposed modifications in the PCCP must be few, specific and capable of being verified and validated within the device’s intended use.
5. PCCPs harmonize with existing FDA Device Modification Guidance. This principle recognizes that this Guidance and others are intended to help a manufacturer assess whether a new marketing submission is required for a modification to its device—whether consistent with an existing PCCP or without a PCCP—so that FDA can continue to support improvement through modifications while providing a reasonable assurance of device safety and effectiveness.

The comment period on this draft Guidance is open until November 20, 2024.

Once this draft Guidance is finalized, FDA has indicated its intent to update other relevant guidance documents to clarify that a PMA supplement or 510(k) is not required for a change to a device consistent with an approved or cleared PCCP. FDA may also update its Guidance on PCCPs for AI/ML-enabled devices and other device-specific guidance documents containing information on PCCPs to be consistent with this Guidance once finalized. Thus, while this Guidance offers recommendations that broadly apply to all device types, FDA clearly intends for manufacturers to continue to refer to their more specific guidance documents if applicable to a manufacturer’s device.

For More Information

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