SILVER SPRING, Md. – The U.S. Food and Drug Administration has released draft guidance on the requirements for clinical evaluation of software-as-a-medical-device (SaMD). The draft guidance is intended to provide “globally harmonized” principles around when and what type of clinical evaluation is appropriate. “Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD,” the guidance states. Public comment on the draft guidance is being accepted.
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