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Special FMMC Briefing: "The 510(k) and Substantial Equivalence"
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Special FMMC Briefing:

When: Friday, February 21, 2020
9:00 AM - 10:30 AM
Where: Research Park @ Florida Atlantic University
3651 FAU Boulevard
Suite 400
Boca Raton, Florida  33431
United States
Contact: FMMC
(850) 270-3158

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"The 510k and Substantial Equivalence: Why do so many get it wrong?"


Special Guest Speaker: Michael Drues, Ph.D.


The premarket notification, a.k.a. the 510K, is the most common pathway used to bring new medical devices to market in the US. Yet despite FDA issuing multiple guidance’s since the 510k was created in 1976, 75% of 510k’s are rejected (i.e., via “additional information” requests) and of those that are rejected, nearly 85% are rejected specifically because of substantial equivalence or the lack thereof! Simply put: no 510k should ever be rejected – and certainly not due to substantial equivalence – this is an amateur mistake! (see MDUFA stats). Such delays and rejections result in obvious increases in time and cost to market – many of which could be minimized or avoided!
One area receiving regulatory scrutiny is the substantial equivalence (SE) argument. Simply put without a strong substantial equivalence argument, your 510k submission will not be successful. And if FDA says your device is not substantially equivalent (NSE), does it mean your device is in fact NSE? Not necessarily! But what does SE really mean and how do I show it? How do I use not just what the regulation says but also what it does not say to my advantage? Using the case study approach, these questions and others will be presented in an interactive fashion. Following this presentation, participants will:


• understand the regulatory requirements of substantial equivalence and how to use them to your advantage
• learn to design a substantial equivalence strategy using regulatory logic and how to defend it
• appreciate the split- and multi-predicate strategies and how and when to use each
• be aware of several new FDA guidance documents and how to use them to your advantage
• learn what to do if FDA says your device is NSE, i.e., does NSE necessarily mean NSE? what are your options?
• discuss the proposed changes currently under debate and what the future may hold for the 510K program
Bottom line: knowing what regulation says, although a good start, is not enough – know how to use it to your advantage!




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