Explaining the Significance of Voluntary Consensus Standards - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:07:08
What are Voluntary Consensus Standards? Why should you care about them? What role do they play in your regulatory submission process?
In this episode, Mike Drues of Vascular Sciences and I discuss the importance of such standards that affect medical device professionals.
Some of the highlights of the show include:
● Guidance and regulation are voluntary. You can comply or not. If something doesn’t make sense, justify why and describe what you plan to do instead.
● FDA’s guidance document provides information on what standards it will accept and recognize. FDA doesn’t recognize all recognized standards.
● There’s a correlation between consensus standards and regulatory pathways. The abbreviated 510(k) is the most important pathway for standards.
● Declaration of Conformity: Provide proof/objective evidence. Companies need to have data/information available, but don’t need to include it in a submission.
● Don’t assume that FDA reviewers are experts in your technology or standard. A company needs to be the expert that makes FDA reviewer’s job easier.
● Standards are not hoops that you have to jump through. They can offer significant, strategic, or competitive advantages.
● Standards that promote the safety and efficacy of your product should be followed, but many are becoming too complicated and don’t make sense.
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