In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier podcast on this topic). The more recent guidance expands the scope to any medical device, whether it has AI/ML or not. Specifically, the following questions are addressed:

• What is a predetermined change control plan and why is it important?
• FDA published two guidances on PCCPs (one last year in April and one just this past August). These two guidances sound similar (maybe substantially equivalent), so what’s the difference?
• What’s the difference between a PCCP for a SaMD with ML or AI different from a PCCP for a non-SaMD device, like a catheter or stent?
• Are there any limits on changes in a PCCP?
• How and when do I submit a PCCP?
• What are the advantages of submitting a PCCP?
• Are there any disadvantages of submitting a PCCP?

Listen to part 2 of this discussion and then see if you have a better understanding of PCCPs. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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