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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.

 

Links:

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

ISO

ASTM

FDA

IEC

UL

Greenlight Guru

 

Quotes:

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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