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Unpacking Averages – How Accurate Must Class II Medical Devices Be in Order to Receive 510(k).


It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. I often respond, very helpfully, “it depends.” But for some reason clients aren’t completely satisfied by that.

I will then say that the general rule is 95%. However, this is only a rule. For Class II medical devices undergoing review through the 510(k) process, the legal standard is that the applicant must show that the device is “substantially equivalent” to devices already lawfully on the market. It’s not a real precise standard. What do the data show about medical devices that have been cleared? This post is devoted to answering that question.

Big Caveats: Reader Beware

In these posts, I usually like to present my results first and then explain them. But before I do that this month, I’m going to give you some big caveats on this.

Informally written summaries of 510(k), available in PDF, are the best way to answer this query. In data…

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