Regulatory Open Forum

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  • 1.  Got any NSEs lately?

    Posted 28-Mar-2018 06:16
    ​If you have gotten an NSE in the past year or so, I'd be interested to hear about your experience (off-line, if you prefer).  If you didn't get one because you withdrew your application when it became clear it would be NSE, I'd be interested in hearing about that, too.

    I'm not that interested in the details of the device or the NSE (maybe whether the NSE issue was intended use and/or technological characteristics), but what happened to the product afterwards, along with how that fit into the company's goals, since I think one-device startups and established device companies with a large catalog of devices may handle an NSE rather differently.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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