Draft Guidance: Software as a Medical Device (SAMD): Clinical Evaluation

• By: Staff Editor
• Date: October 25, 2016
• Source: ComplianceOnline

Draft Guidance: Software as a Medical Device (SAMD): Clinical Evaluation

The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.

The guidance states, "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."

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