Predetermined Change Control Plans, Part 2

Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1, click here to do so. Specifically, the following questions are addressed in part 2:

• You have submitted a PCCP with a previous regulatory submission, but you have not yet made the actual, real-world change to the device. Can that PCCP submission, assuming it was approved, be used as a predicate for a 510k submission?
• For what types of devices should I consider a PCCP?
• Can you provide a few examples of PCCPs?
• Can PCCPs be used for manufacturing?
• Since the use of a PCCP is relatively new, can you think of what questions could potentially arise? What questions might we not have just yet?
• Anything else you’d like to say about the use of a PCCP we haven’t covered?
• What are the important takeaways?

After both parts, do 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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