Predetermined Change Control Plans (PCCP) for Medical Devices

The FDA has recently issued a draft guidance for Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance, when finalized, will represent the FDA’s current thinking on “Predetermined Change Control Plans for Devices.” Comments, either electronic or written, can be submitted on the draft guidance by November 20, 2024, to ensure that the Agency considers your input before beginning work on the final version of the guidance.

To read the full FDA guidance on PCCP for Medical Devices click here.

Navigating FDA’s Draft Guidance on PCCP for Medical Devices

The US Food and Drug Omnibus Reform Act of 2022 (FDORA) gave the FDA the authority to approve a PCCP. Software and Artificial Intelligence (AI) devices are currently on the rise in the market. These devices usually undergo frequent changes during their life cycle. As such, the FDA has now embraced its responsibility for approving Predetermined Change Control Plans for devices as part of manufacturers’ pre-market submissions, such as a 510(k), De Novo, or PMA.

To learn more about how you can streamline your medical device to the US market, click here.

The PCCP allows for medical devices to change after marketing authorization if those changes are pre-specified and agreed to by the FDA. Changes with an approved PCCP do not require a supplemental application. This provision applies to all devices. Manufacturers can use the Q-Submission process to obtain FDA feedback on a proposed PCCP prior to submitting a marketing submission or use an industry expert to assist with this plan. Feedback obtained during the Q-Sub process would not constitute approval of the PCCP, which must be obtained at the time of clearance/approval of the marketing application. Future changes to the PCCP may trigger the need for a new marketing application. Additionally, the eSTAR template now has the option to add the PCCP. The FDA views PCCPs as an approach to increasing the pace of medical device innovation in the United States and enabling more personalized medicine.

The draft guidance proposes recommendations on the types of modifications that, at this time, the FDA believes generally may be appropriate for inclusion in a PCCP, and the information that should be included in a PCCP in a marketing submission for any device type. By including a PCCP in a marketing submission, 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. Additionally, because PCCPs are appropriate for device modifications that generally would otherwise require a new marketing submission, the draft guidance does not address change plans that contain only proposals for modifications that would not require a new marketing submission.

What Should be Included in a PCCP for Medical Devices

A PCCP should consist of 1) a detailed Description of Modifications, 2) a Modification Protocol, and 3) an Impact Assessment. The detailed Description of Modifications outlines the specific, planned modifications that may be made to the device. The Modification Protocol describes the verification and validation activities, including predefined acceptance criteria, that will support each modification to ensure the device remains safe and effective when used as intended. The Impact Assessment ties the Description of Modifications to the Modification Protocol by identifying the benefits and risks introduced by the specified, planned modifications and addressing how the verification and validation activities of the Modification Protocol will continue to ensure the device’s safety and effectiveness.

Importance of Compliance with Quality System Regulations for PCCP in Medical Devices

A manufacturer’s quality system is critical for change management processes for a device, especially for devices that include a PCCP, because a PCCP includes modifications that generally would otherwise require a new marketing submission. Compliance with the QSR is essential for a manufacturer to implement modifications consistent with their authorized PCCP, and failure to do so could potentially present a serious risk to human health. The FDA can deny approval of a PCCP submitted in a PMA if it finds that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or installation of the subject device do not conform to QSR requirements. For devices subject to 510(k), the FDA may withhold a substantial equivalence determination if it finds there is a substantial likelihood that failure to comply with the QSR could present a serious risk to human health. The FDA could make such a determination based on a manufacturer’s regulatory history that demonstrates failure to comply with QSR. The draft guidance also indicates the FDA’s determination of substantial equivalence regarding technological characteristics will include the PCCP to ensure any differences do not raise different questions of safety and effectiveness. Future changes to an authorized PCCP will require FDA review and authorization through a 510(k) or PMA supplement. PCCPs should be version-controlled within the manufacturer’s QMS to ensure future changes can be tracked as required.

Criteria for Including Modifications in a PCCP

Modifications appropriate for inclusion in a PCCP include those intended to maintain or improve the safety or effectiveness of the device. Modifications should be specific and able to be verified and validated. Modifications included in a PCCP should maintain the device within its intended use, and, as applicable, must allow the device to remain substantially equivalent to the predicate device. Depending on the type of marketing authorization—PMA versus 510(k) and De Novo—different types of modifications might be appropriate to include in a PCCP.

Modifications Acceptable for PCCP for a 510(k) or De Novo Device

Some examples of acceptable modifications to include in the PCCP for a 510(k) or De Novo Device include:

• • Certain changes in software consistent with the intended use to improve device performance.
  • Certain changes in device design, including dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface.
  • Certain changes in materials/components (e.g., different raw materials, reagents, or hardware components).
  • Certain changes in software related to device compatibility and/or interoperability (e.g., changes to support device use on additional operating system(s), new data vendors and/or sources, or compatibility with additional devices).

Modifications NOT Appropriate in the PCCP for a 510(k) or De Novo Device

Some examples of acceptable modifications NOT appropriate to include in the PCCP for a 510(k) or De Novo Device include:

• • Change in device design that could affect the intended use of the device.
  • Change to or removal of contraindications.
  • Change to address a recall or safety issue.
  • Change from prescription to over-the-counter use.

Modifications Acceptable in the PCCP for a PMA Device

Some examples of acceptable modifications to include in the PCCP for a PMA Device include:

• • Minor change in software consistent with the intended use to improve device performance.
  • Minor change in device design, including dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface.
  • Minor change in sterilization, packaging, transport, or expiration dating.
  • Minor change in software related to device compatibility and/or interoperability (e.g., changes to support device use on upgraded operating system(s) or new data vendors and/or sources).

Modifications NOT Acceptable in the PCCP for a PMA Device

Some examples of acceptable modifications NOT appropriate to include in the PCCP for a PMA Device include:

• • Significant change in labeling such as a change to or removal of contraindications.
  • Change to address a recall or safety issue
  • Change to a device constituent part that impacts the biologic or drug constituent part.
  • Change to add, expand, or move the manufacturing or sterilization site of a finished device.

Guidance on PCCP for Medical Devices with MedEnvoy

The final version of the guidance would likely have some changes after FDA incorporates feedback from comments received by November 20, 2024. MedEnvoy can assist manufacturers with proposing revisions to the draft guidance to ensure their specific concerns are considered in the final guidance. MedEnvoy could also assist with Q-Submissions to gain FDA feedback on a PCCP, drafting the PCCP or advise on the overall PCCP strategy. To contact our team, click here. To learn more specifically about our FDA service, click here.

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