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Hi,
Has anyone worked with any Class II non-invasive continuous digital monitoring medical device and gotten market clearance in USA? I am trying to put together a regulatory plan for Class II non-invasive continuous digital monitoring medical device. Gen 1.0 of the device is already cleared as spot-checking device. If the company is able to collect enough clinical data to support the changed Indication for Use for continuous monitoring, can the gen 2.0 device go through Special 510(k) if there are no standard or guidance around the essential performance or clinical validation requirements? Please suggest.