FDA Won't Regulate Medical Device Data Systems

Draft guidance published Friday by the U.S. Food and Drug Administration seemingly paves the way for smoother medical device interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements.  The guidance notes that "additional experience" with MDDS since down-classifying such tools from Class III devices, which are considered high-risk, to Class I (low-risk) in February 2011 prompted FDA's decision to "not enforce compliance with ... regulatory controls." Such tools, the guidance notes, are not intended to control or "alter the functions ... of any connected medical devices," but rather:

• Enable electronic transfer or exchange of medical device data: The guidance gives the example of software that collects output from a ventilator on a patient's CO2 level, transmitting that data to a central repository
• Store and retrieve medical device data, such as historical blood pressure information that can be reviewed by a physician...