Making MedTech Happen with RQM+

Live! #68 – Pre-Submission to Preeminence: Showcasing FDA's Latest Pre-Sub Guidance and Uncovering PCCP Best Practices

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This show was recorded 29 June 2023 and can be viewed on our website here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠. Thank you for listening!

This panel discussion was all about the FDA's latest pre-submission guidance, with an emphasis on best practices for Predetermined Change Control Plans (PCCP). As always, we took questions from the audience and answered as many as we could! 

Key points of discussion included:

  • Unveiling FDA's new pre-submission guidance and its implications 
  • Pros and cons of implementing pre-submission meetings for regulatory success
  • Leveraging pre-submission meetings for QSR follow-ups and risk mitigation
  • A thorough exploration of PCCP (beyond just software); some specifics include:
      • Applicable to PMA and 510(k) devices (previously not available for 510k devices unless the predicate had one)
      • Includes labeling for the proposed change and performance requirements for changes made under the plan
      • Allows manufacturers to make pre-planned changes without a new submission
      • If choosing a predicate, it must be what was reviewed by FDA and not the device version that underwent a change control plan
        • Understanding the 2022 Omnibus Appropriations Bill: Streamlining PCCP submissions
        • How RQM+ empowers clients with comprehensive support in this area, from package preparation to remediation 

          • Don't miss this opportunity to explore the advantages, potential challenges, and optimal approaches to leverage pre-submission meetings and PCCPs. We hope you’ll join our experienced and versatile team as they explore these topics and answer your questions.

          Panelists:

          • Nancy Morrison, RAC – Vice President, Intelligence & Innovation
          • Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
          • Hrishikesh Gadagkar – Principal Engineer
          • Bryan Pinder, RAC – Principal Engineer (former FDA CDRH Lead Reviewer)
            • ...more
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