Episode Details

This is the audio-only version of RQM+ Live! #40, originally recorded 30 September, 2021.
 
This 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 panelists:
  • 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)
Questions answered:
  • How do you push back on FDA when you don't agree?
  • Where did the phrase least burdensome come from and what does it actually mean?
  • Does FDA hate to hear the words least burdensome?
  • Do you actually write the words "least burdensome?"
  • What's the difference between the least burdensome flag with the new process and an appeal?
  • Should a manufacturer be weary of using the least burdensome flag process, or appealing in general?
  • Can a reviewer handle a least burdensome flag on their own? Could they resolve it?
  • How do you balance timing? (going through the proper steps before appealing and throwing the flag, but keeping other time restrictions in mind)
  • When should you file a formal appeal vs. throw the least burdensome flag?

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