What is Clinical Evaluation for SaMD?
The FDA defines clinical evaluation for SaMD (Software as a Medical Device) as a set of ongoing activities conducted in the assessment and analysis of SaMD’s clinical safety, effectiveness and performance as intended by the manufacturer in the SaMD’s definition statement1. Conducting a thorough clinical evaluation of a SaMD product is essential because the FDA requires clinical evidence for safety and efficacy before market approval. Clinical evaluation for SaMD consists of three key steps: establishing clinical association, analytical validation, and clinical validation.
The extent of clinical evaluation activities depends on the risk profile of the product. In 2017, the FDA released guidance on Software as a Medical Device (SaMD) Clinical Evaluation, outlining the clinical evidence requirements for SaMD products.
