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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.



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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.



Recognition and Withdrawal of Voluntary Consensus Standards

Recognized Consensus Standards Database

Latest Updates on CDRH Standards Program & IEC 60601

How to Prepare an Abbreviated 510(k)

ISO 10555-1:2013

De Novo Program

Mike Drues






Greenlight Guru



All guidance, all regulation is voluntary. We can either comply with it or not. - Mike Drues

Don’t follow (standards) blindly. Make sure it makes sense to what you’re doing. - Jon Speer

Don’t assume that the FDA reviewers are experts in your particular technology or in (a) particular standard. - Mike Drues

People think that standards are just more hoops you have to jump through. (But) there are some very significant, strategic, or competitive advantages. - Mike Drues



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