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June 15, 2023

Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time & Cost to Market

According to 2022 statistics, the average cost to obtain a 510(k) from concept to clearance is $6.1M ($200K-$41M) and the average clearance time is 33 months (2 months-11 years).

So why does it take so long and cost so much? Showing substantial equivalence or the lack thereof is without a doubt one of the biggest reasons for 510(k) delays and rejections!

The premarket notification, a.k.a. 510(k), is the most common pathway used to bring new medical devices to market in the US. Yet despite FDA issuing multiple guidances since the 510(k) was created, 75% of 510(k)s are rejected (i.e., via “additional information” requests) and of those rejections, nearly 85% are rejected specifically because of substantial equivalence or the lack thereof!

Simply put: no 510(k) should ever be rejected – and certainly not due to substantial equivalence – this is an amateur mistake! (May, 2023 MDUFA stats).

Such delays and rejections result in increases in time and cost to market – most of which could be minimized or avoided!

Bottom line: the better you understand what substantial equivalence means and how to prove it, the less time and cost of your 510(k) – it’s as simple as that… or is it?