The Food and Drug Administration has proposed reclassifying medical-device data systemstechnology that electronically stores, retrieves and transmits condition history such as blood pressure or glucose levels from a patient's medical devicefrom Class 3 medical devices to Class 1.
The move would downgrade medical-device data systems from the most stringent and expensive regulatory classification, which requires FDA pre-market approval, to the lowest-risk category. Under the proposed rule, both medical-data devices intended for home use by a patient and for use in a professional setting would become Class 1 devices. The move would not include medical-data devices with diagnostic or alarm functions.
The FDA is accepting comment on the proposed rule until May 8.