Simplifying Substantial Equivalence In FDA Premarket Notifications

The FDA’s 510(k) premarket notification process is the most common pathway new medical devices take to market in the United States. And while most 510(k) submissions are eventually cleared, almost 75 percent of first-time applications are initially rejected. It’s no wonder it’s taking an average of 114 days for 510(k)’s to be review time in 2014, and that’s actually an improvement over years past!

Staying current on 510(k) guidance is critical to making the process go as smoothly as possible, and the agency has issued quite a few related guidance documents in recent months. In this podcast, Michael Drues, Ph.D., author of the Med Device Online guest column series Guerilla Regulatory Strategy, shares some 510(k) submission strategies and explains how two recent guidances — on the topic of substantial equivalence — should influence your approach.

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