FDA Remote Medication System Guidance

FDA issued a “Class II Special Controls Guidance Document: Remote Medication Management System” and a classification notice reclassifying such devices from Class III to Class II subject to this guidance document as a special control. Such systems include the remote portion and the medication delivery system and the software is considered Major Level of Concern. Although an abbreviated 510(k) can be submitted using this guidance as a special control it states that software information included should be based on that required by FDA’s general software guidance for Major Level of Concern software. This guidance also has specifics in terms of simulated use testing expected and lists security as one of the system risks to be addressed. A full copy of the guidance is at the link provided.