Episode Details

This is the audio from RQM+ Live! #46, originally recorded 13 January, 2022.

As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022.

This discussion will cover the following and more:

  • Impact of COVID on FDA resources and submission timelines in 2021
  • Updates on breakthrough and new developments for innovative devices, such as the Safer Technologies Program (STeP) 
  • FDA Process Improvements, including the eSTAR pilot
  • FDA 2022 focus areas, including MDUFA V Negotiations expectations and CDRH 2022 Guidance Priorities
  • Kevin Go – Project Engineer, RAC – RQM+ (former FDA CDRH Lead Reviewer)
  • Allison Komiyama, Ph.D., RAC – Former Founder and Principal Consultant, AcKnowledge Regulatory Strategies (now with RQM+)
  • Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, RQM+
  • Bryan Pinder – Project Engineer, RAC – RQM+ (former FDA CDRH Lead Reviewer)
  • Ryan Randall – Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer)

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