Federal Register Notice: U.S. Food & Drug Administration’s Clinical Evaluation Of Software As A Medical Device (SaMD)

On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced the availability of this draft guidance pertaining to the conduct of clinical evaluation of Software as a Medical Device (SaMD). The guidance focuses on general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD, and is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD . . .