Hi Cabe,
Medical device approval can be shorter than the approval of a drug spending on the device “class”. As Wheezo is a “monitoring & measurement” device it is considered a Class 1 medical device.. The timeframe for this Class of device approval through the FDA can be up to 6 months and maybe shorter depending if the company applies for a 510k exemption based on previous data proving its safety and effectiveness (previous clinical trials).
Ann: FDA submission to be lodged, page-6
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