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.