For the first year or two after FDA released its Refuse to Accept (RTA) policy, I occasionally saw reports of the percent of 510(k)s that had been refused under the new policy, eg. almost 60% in the first nine months. I haven't seen any updated statistics lately. Does someone here have a recent figure? And does anyone know if this information is officially available somewhere?
------------------------------
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------------------------------