Episode Details

This is the audio-only version of RQM+ Live! #37, originally recorded June 17, 2021.
The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need them.
We often get the questions, "Where do I start?" and "How do I know if my device qualifies?" In this Live! show, our panel of regulatory experts (including former FDA CDRH representatives) will discuss the following and more:
  • Is your device really innovative? Everyone thinks their product is the best thing since sliced bread but will FDA agree?
  • Tips and tricks when considering these programs - STeP, Breakthrough, CDRH Innovation/CDRH Payor communication task force
  • The STeP Program being new, what should you expect from the Agency initially, and what are the uncertainties around how the STeP will be applied
  • Is FDA responding to Q-sub requests from innovators during the pandemic?
  • Is clinical data needed before submitting the breakthrough application or is it dependent on the device/OHT?
  • Is being “innovative” worth it if it will require additional clinical evidence?
  • Where are we seeing ‘Innovative Devices’ emerge and where do we think the industry is headed?
If you'd like to learn more about the options and challenges associated with getting innovative devices to the US market, please join us and bring your tough questions for our panel to answer live!
The panel will include:
  • Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
  • Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer)
  • Bryan Pinder - Project Engineer (former FDA CDRH Lead Reviewer)

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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