New FDA Draft Guidance - Predetermined Change Control Plans
- swichansky2
- Sep 5, 2024
- 3 min read
On August 22, 2024, the FDA issued a new draft guidance document titled “Predetermined Change Control Plans for Medical Devices”. A Predetermined Change Control Plan (“PCCP”)describes the modifications that will be made to the device and how the modifications will be assessed. The FDA reviews the PCCP as part of a marketing submission (PMA, 510(k), De Novo) to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification. This guidance document includes a policy for PCCPs, the types of modifications appropriate for a PCCP, and recommendations regarding the information to include for a PCCP within a marketing submission. At a high level, the FDA is recommending that a PCCP include (i) a description of the planned device modifications, (ii) the associated methodology to develop, validate, and implement those modifications, and (iii) an assessment of the impact of those modifications.
By including a PCCP in a marketing submission for a device, 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.
The FDA reasserts five guiding principles that should be considered with respect to PCCPs, all of which are covered in more detail within the guidance document:
1) Reasonable assurance of safety and effectiveness and substantial equivalence of devices with PCCPs
2) PCCPs may be a least burdensome option to support device modifications
3) PCCPs are part of a device’s marketing authorization
4) PCCPs are specific
5) PCCPs harmonize with existing FDA Device Modifications guidance
Further, the FDA describes the three sections to be included in a PCCP as follows:
1) A detailed Description of Modifications – includes defining the specifications for the characteristics and performance of the planned modifications
2) A Modification Protocol – describes the verification and validation activities, including pre-defined acceptance criteria, that will support each modification
3) An Impact Assessment – identifies the benefits and risks presented by the planned modifications and addresses how the verification and validation activities within the Modification Protocol will continue to assure safety and effectiveness of the device
The PCCP should be a separate, stand-alone section within the marketing submission, it should be prominent, it should be discussed in the cover letter, and it should be specifically called out in the table of contents for the marketing submission. The PCCP should be described in publicly available device summaries, including, for example, the PMA summary of safety and effectiveness document (SSED) and approval order, 510(k) summary, or De Novo decision summary. Details of the PCCP should be included in sufficient detail in the public-facing documents to support transparency to users of the assessment of reasonable assurance of safety and effectiveness or the substantial equivalence comparison for the device and the device’s specifications.
When device manufacturers ultimately implement modifications included in an authorized PCCP, the FDA expects such modifications to be consistent with such authorized PCCP. A manufacturer’s quality system is critical for change management processes for a device, especially for devices that include a PCCP since a PCCP includes modifications that generally would otherwise require a new marketing submission.
The FDA urges medical device stakeholders to engage early and proactively with the FDA regarding a proposed PCCP, especially for certain device types including combination products and high-risk, life-sustaining, life-supporting, or implantable devices. Medical device companies should take full advantage of the Q-Submission Program for soliciting FDA feedback on a PCCP prior to submitting the applicable marketing submission.
Should you need any assistance with your PCCP or your medical device marketing submissions in general, please feel free to reach out to our team at PRP.
