A new draft guidance issued by US FDA seeks to define principles for when clinical evaluation is necessary and what types of studies are needed for software that qualifies as a medical device. But in an unusual circumstance, the guidance was not written by FDA alone; it was produced by a team of regulators from across the globe, under the auspices of the International Medical Device Regulators Forum.
The US agency posted the IMDRF draft document, "Software as a Medical Device: Clinical Evaluation," on Oct. 13...
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