Best practices for success with PCCP

Predetermined Change Control Plan (PCCP) is an excellent tool for speed to market, but it requires strategic and disciplined approach. Consider these best practices for regulatory success.

A Predetermined Change Control Plan (PCCP) is a new regulatory scheme that allows medical device manufacturers to implement post-market changes to their devices without requiring additional marketing submissions to the FDA, provided the changes are consistent with the authorized PCCP.

It can help device manufacturers gain speed to market by lowering the regulatory burden. This approach is particularly important for software and AI/ML-based medical devices due to their fast pace of innovation and the need for adaptive algorithms.

FDA has recently finalized a PCCP guidance for AI/ML enabled devices¹ and a draft guidance for medical devices in general². Since then, the number of pre-market submissions with an authorized PCCP has steadily increased. However, use of a PCCPs in pre-market submissions is still more of an exception than a norm.

One reason is that preparing a PCCP for FDA review and authorization is not an easy task. It requires careful planning and disciplined execution. It takes a lot of resources, and if not done correctly, it can actually hinder your speed to market. According to the FDA guidance, a PCCP for an AI/ML device must include the following elements:

1. Description of modifications

2. Modification protocol: data management practices, re-training practices, performance evaluation, update procedures and traceability to description of modifications, and

3. Impact assessment: benefit-risk, verification/validation activities, interaction among different modifications and how they impact device safety and effectiveness, cumulative impact.

In this article, we share 5 best practices for success with PCCPs. These best practices are based on recent Let’s Talk Risk! podcasts, case studies and FDA guidance.