FDA Pressed To Classify Drug Risk Score Software As A Device

FDA has been petitioned to classify a commonly used software tool that gives providers a score assessing patients’ probability of abusing prescription drugs as a medical device, with the petitioners saying the program has caused patients to being denied needed pain medications and must be recalled unless it is regulated as a device. The move comes as FDA attempts to increase its oversight of clinical decision support (CDS) software that provides specific recommendations about the treatment of patients. The nonprofit...