RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA Submissions

Device Advice by RQM+

This is the audio from RQM+ Live! #46, 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

The panel of former FDA CDRH and industry subject matter experts:

• 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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Questions:

3:40 -- What was 2021 like on the inside at FDA?

13:21 -- Could you summarize the updates and changes at FDA in 2021?

14:52 -- Allison, you've worked on many STeP applications - what's been your experience?

20:08 -- Let's talk about the eSTAR program... good, bad, any experience with it so far?

27:21 -- What is new in digital health at FDA?

31:58 -- Are you able to get Q-Sub meetings now?

33:17 -- What's taking up FDA's time? It can't be EUA's, right?

35:37 -- Is there any data on the clearance time using eSTAR? (the answer is no)

36:00 -- How about the status of EUAs... what's going on with them?

40:35 -- Any other impactful changes at FDA that people should be aware of from 2021?

46:47 -- What about biocompatibility?

48:10 -- How about MDUFA?

49:06 -- Any other key things anyone wants to point out before we wrap up?

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Next RQM+ Live! show:

• 27 January: RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong?

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About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.

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