Who's In Control Of Your Medical Device's FDA Classification?

Medical device classification should be a pretty simple exercise, but as with most regulatory matters, it's not always as straightforward as it seems. In an effort to shed some light on the FDA's classification and reclassification process, Med Device Online’s Jim Pomager connected with Dr. Michael Drues during the MD&M East 2014 conference in New York City. Mike is president of education and consulting company Vascular Sciences and a regular contributor on regulatory matters to Med Device Online. In this podcast, he discusses the typical routes medical device manufacturers take to device classification, how they can influence their device’s classification, and why that can be to their competitive advantage.

**If you are interested in learning more about device classification and reclassification, check out Dr. Drues’ 90-minute online course on the subject, Understanding the Medical Device Classification System: Best Practices for Selecting the Best Fit, which will take place on July 15, 2014, at 1 pm EDT time. For more information or to register, visit here.

Music credit: Morning Blue (Instrumental) (Josh Woodward) / CC BY 3.0