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:

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

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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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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.