"The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest."
'via Blog this'
View the draft guidance:
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability
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