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Wednesday, 08/12/2020 9:51:29 PM

Wednesday, August 12, 2020 9:51:29 PM

Post# of 97083
READ “Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. These studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. https://www.fda.gov/media/81784/download THIS IS WHY BERMAN CAME DOWN ON THE FDA.