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:

Questions answered:

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About RQM+

RQM+ is the leading international provider of regulatory, quality and compliance 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.