Business · 08/12/2017
FDA Announces Availability of Guidance on Software as a Medical Device Clinical Evaluation
The Food and Drug Administration (FDA) has released a guidance document outlining principles for clinical evaluation of Software as a Medical Device (SaMD), developed in collaboration with the International Medical Device Regulators Forum (IMDRF) and informed by public comments.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →