The Food and Drug Administration has released draft guidance for public comment on the clinical evaluation of software as a medical device (SaMD), with significant implications for the growing number of digital health and mobile applications entering the healthcare marketplace.

Developed by the International Medical Device Regulators Forum (IMDRF) and endorsed last month by IMDRF’s management committee, the FDA draft guidance provides recommendations for medical device manufacturers on the methods of clinical evaluation and the level of clinical evidence necessary to support the use of SaMD.

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