New Draft Guidance on Predetermined Change Control Plans for Medical Devices

09/18/2024

A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance is in regards to the addition of section 3308, 515C “Predetermined Change Control Plans for Devices” to the Federal Food, Drug, and Cosmetic Act (FD&C) on December 29, 2022.  515C allows the FDA to approve/clear PCCPs for devices requiring pre-marketing approval (PMA) or pre-market notification 510(k) without the manufacturer having to submit a new PMA or 510(k) assuming the modification to the device is consistent with an approved/cleared PCCP.

The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances. It also contains a potential policy for PCCPs, guiding principles, and information the FDA recommends be included in a PCCP for a marketing submission. The guidance proposes that the following four sections be included in in a PCCP:

  • Description of Modification: The PCCP should identify each specific, planned modification the manufacturer intends on implementing to a device with a high level of detail to facilitate the readers understanding of the changes being made. While multiple modifications are permitted in a single PCCP, it is recommended that the number of individual modifications be limited to ensure efficient review and that each modification be linked to a specific performance evaluation activity within the Modification Protocol.

  • Modification Protocol: This section should include the methods followed while developing, validating, and implementing each modification to maintain the safety and efficiency of the device. The content of the Modification Protocol can be further broken down into two subcategories:

    • Performance Evaluation Methods: this includes plans to verify and validate the modifications specified in the PCCP and that the device as a whole still preforms as intended with the same levels of safety and efficacy as the original.

    • Update Procedures: this should include how the manufacturer intends to update the device when the modifications are implemented as well as post-marketing surveillance plans that will ensure the device is functioning as intended.

  • Traceability Between the Description of Modifications Section and the Modification Protocol Section: as the title suggests this section should clearly connect each described modification to the appropriate modification protocol to facilitate the reading and comprehension of those reviewing the PCCP.

  • Impact Assessment: the final section should include the benefits and risks, especially risks of harm, of implementing the modifications to the device. If there are multiple modifications this section should outline how the implementation of one may impact the other. The FDA recommends that the impact assessment be referenced where appropriate in the modification protocol section.

The full guidance is on the FDA’s website, it is open to comment submission from now until November 20, 2024. Those who wish to submit a comment may do so here.

-The Clinical Pathways Team

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