The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.
One of the draft guidances, the 13-page “Clinical and Patient Decision Support Software,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medical device, and thus would not be regulated.
FDA on Wednesday also issued a final guidance developed with the International Medical Device Regulators Forum (IMDRF), known as “Software as a Medical Device: Clinical Evaluation.” Drafted in October 2016, the final guidance expands on that draft and establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). This final guidance provides globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product.
To read the article by Zachary Brennan