What is a pre-determined change control plan (PCCP)?
The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after they are authorized. The agency introduced a new regulatory framework called pre-determined change control plans (PCCPs), which allows certain post-market changes to devices using AI or machine learning. PCCPs were first mentioned in a 2019 discussion paper, and the FDA has since issued draft and final guidance on them.
PCCP Required Information
This final guidance outlines the required information for PCCPs, which includes;
- Description of Modifications – The specifications for the characteristics and performance of the planned modifications to the device;
- Modification Protocol – The associated verification and validation testing activities that will support the planned modifications and acceptance criteria to assure the device remains safe and effective across the intended use populations
- Impact Assessment – The assessment of the benefits and risks of implementing a PCCP, as well as the plan for risk mitigation.
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Manufacturers can propose updates to AI models, such as re-training to improve accuracy, without needing new submissions, as long as the changes stay within the device’s intended use. However, significant modifications outside the scope of the PCCP, like altering a device’s function or user base, would require new FDA submissions.
How do you establish a pre-determined change control plans (PCCPs) for my medical device?
Premarket authorization for AI-enabled devices with a PCCP must be established through the PMA pathway, 510(k) pathway, or De Novo pathway as a PCCP must be reviewed and established as part of a marketing authorization.
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