Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh?

FDA defines MDDS as any hardware or software that transfers, stores, converts, and or/displays medical device data. To be considered an MDDS, the product can’t modify either the data or its display. It also can’t, by itself, control the functions of a medical device. An MDDS isn’t supposed to be used for active patient monitoring. The FDA’s MDDS examples include software that:
• Stores patient data such as blood pressure readings for review at a later time
• Converts digital data generated by a pulse oximeter into a format that can be printed
• Displays a previously stored electrocardiogram for a particular patient

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