FDA/IMDRF Draft–Standalone SWClinical Evaluation

OBSOLETE – Final Issued December 8, 2017FDA issued a draft guidance developed as part of the Internation Medical Device Regulators Forum entitled “Software as a Medical Device (SaMD): Clinical Evaluation”. This document focuses on how to demonstrate clinical validatity of software as a medical device. Other guidances from FDA and IMDRF address other software aspects such as software validation, premarket submissions, and risk classification among others.

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