What’s the best approach to get the results you desire while not becoming FDA’s arch nemesis?

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RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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RQM+_Live_40_v2This has been a very common question from device manufacturers since FDA issued guidance on “least burdensome” almost 20 years ago. FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.

Some manufacturers have strong opinions about pushing back on FDA with the argument of utilizing the least burdensome approach, while others are very hesitant to burn bridges. What’s the best approach to get the results you desire while not becoming FDA’s arch nemesis? Join our regulatory experts including former FDA CDRH representatives for a detailed discussion on the process and best practices for disagreeing with FDA.

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)
  • Ryan Randall - Senior Engineer (former FDA CDRH Lead Reviewer)

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer