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The Food and Drug Administration has issued draft guidance for public comment on the clinical evaluation of software as a medical device, or SaMD (PDF), which could impact the expanding number of digital health and mobile apps.

The guidance, which was developed by the International Medical Device Regulators Forum, of which the FDA is a member, offers recommendations for medical device manufacturers on the methods of clinical evaluation and the level of clinical evidence necessary for a SaMD, according to a report in Health Data Management.

“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develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD,” according to the draft guidance.

A medical device, as defined by the regulators forum, includes instruments, machines, implants, software to be used in the diagnoses, prevention, monitoring, treatment and alleviation of disease. SaMD also can apply to software that provides means and suggestions for mitigating a disease as well as information for detecting, diagnosing, monitoring and treating states of health and illnesses.

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