Predetermined Change Control Plans for Medical Devices

Predetermined change control plans (PCCPs) are a way of managing certain device changes where regulatory authorization is typically required. The term PCCP describes a plan, proposed by a manufacturer, that specifies:

• The planned modifications: Description of the specific, planned modifications that may be made to the device, including the characteristics and performance of the planned modifications
• The modification protocol: Description of the verification and validation activities, including pre-defined acceptance criteria, which will support each modification to the device to ensure that the device remains safe and effective across the intended use populations.
• The impact assessment: Description of the benefits and risks introduced by the planned modifications and addresses how the verification and validation activities of the modification protocol will continue to assure the safety and effectiveness of the device.

PCCPs can be used to help manage risks in a timely and ongoing fashion through monitoring, maintenance, and/or improving device performance while upholding the high regulatory standards to ensure device safety and effectiveness. PCCPs are optional, however, including a PCCP in a marketing submission for a device would allow manufacturers to prospectively specify and seek premarket authorization for intended modifications to a device without the need for additional marketing submissions or obtaining further FDA authorization before implementing such modifications.

In August 2024, FDA issued a draft guidance outlining the Agency’s thinking on PCCPs and the recommended information to be included in marketing submissions for medical devices.¹ This guidance comes on the heels of the 2023 draft guidance for PCCPs for AI/ML-based software.²  However, the current draft guidance is applicable to all types of medical devices, including those for Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD), with or without AI/ML-enabled software functions.

If approved, this guidance will affect other pertinent guidance documents, including:

• Deciding When to Submit a 510(k) for a Change to an Existing Device³
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device⁴
• Modifications to Devices Subject to Premarket Approval (PMA) -The PMA Supplement Decision-Making Process⁵
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions²

FDA follows these guiding principles in its considerations of PCCPs:

1. Reasonable assurance of safety and effectiveness and substantial equivalence of devices with PCCPs – Device submissions with PCCPs must meet the statutory standard of reasonable assurance of safety and effectiveness, including substantial equivalence for 510(k)‑cleared devices. In 510(k) submissions, if a predicate device was authorized with a PCCP, the subject device must be compared to the version of the predicate device cleared or approved prior to changes made under the authorized PCCP.
2. PCCPs may be a least burdensome option to support device modifications –Manufacturers can leverage the PCCP approach to implement modifications to their medical devices without the need for additional marketing submissions while continuing to provide a reasonable degree of safety and effectiveness.
3. PCCPs are part of a device’s marketing authorization – a manufacturer is required to implement modifications according to their authorized PCCP for a specific device. FDA would consider it to be a deviation from the authorized PCCP in circumstances where the PCCP is not/cannot be followed. Deviations from the authorized PCCP could significantly affect the safety or effectiveness of the device.
4. PCCPs are specific – A PCCP should include only those modifications that a device manufacturer intends to make over time, and which would otherwise require a new marketing submission before implementation. A PCCP should include only a few, specific modifications that can be verified and validated. These modifications 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.
5. PCCPs harmonize with existing FDA Device Modifications guidances – Device Modifications guidances can help manufacturers in determining if a new marketing submission is required for a modification to their device, particularly when the device does not have a PCCP, or when the modification is not consistent with the PCCP.⁶

FDA notes that a PCCP, when submitted, should be a standalone section in a marketing submission application. However, the PCCP should also be discussed in all relevant sections, including the device description and labeling. Specifically, the labeling should be updated to inform users of the implemented modifications, how they were implemented, and their impact, as appropriate.

The draft guidance provides several examples of changes that are or are not appropriate for inclusion in PCCPs in marketing submission applications. Medical device manufacturers are strongly encouraged to refer to these examples, other recommendations in this draft guidance, and make use of the Q-submission program⁷ when developing a PCCP for their medical device marketing submissions.

Since this draft guidance was published on August 22, 2024, it has received six public comments. These comments raise a variety of questions, such as how the FDA intends to monitor and enforce adherence to the PCCP as well as specifics of when a modified PCCP can be submitted. Furthermore, commenters questioned if a specific PCCP can be applied to multiple devices of the same device family which have different intended uses but similar technology and test protocols.

Overall, medical device manufacturers should consider including a PCCP with their marketing submission as FDA strongly encourages its utility as a cost-effective and least burdensome measure to implement changes that would otherwise require new submissions. Manufacturers are also encouraged to contact FDA, via a pre-submission request, to discuss the various elements of the PCCP before finalizing their marketing submission.

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References

1. Draft Guidance for Industry and Food and Drug Administration Staff “Predetermined Change Control Plans for Medical Devices.” August 2024. https://www.fda.gov/media/180978/download
2. Draft Guidance for Industry and Food and Drug Administration Staff “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” April 2023. https://www.fda.gov/media/166704/download
3. Guidance for Industry and Food and Drug Administration Staff “Deciding When to Submit a 510(k) for a Change to an Existing Device” October 25, 2017. https://www.fda.gov/media/99812/download
4. Guidance for Industry and Food and Drug Administration Staff “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”  October 25, 2017. https://www.fda.gov/media/99785/download
5. Guidance for Industry and Food and Drug Administration Staff “Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process” December 11, 2008. https://www.fda.gov/media/81431/download
6. 21 CFR 807.81(a)(3) and 21 CFR 814.39(a)
7. Guidance for Industry and Food and Drug Administration Staff “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” https://www.fda.gov/media/114034/download

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