In early 2008, departing somewhat from the 1989 approach, FDA proposed a new category of software that would fit within this general category of regulated software exempt from premarket clearance. They proposed to call the new category medical device data systems (MDDS), and they defined it to include:
The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices. For example, this would include software that interrogates a ventilator every 15 minutes and transfers information about patient CO\2\ levels to a central patient data repository;
The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices. For example, this would include software that stores historical blood pressure information for later review by a healthcare provider;
The electronic display of medical device data, without altering the function or parameters of connected devices. For example, this would include software that displays the previously stored electrocardiogram for a particular patient;
The electronic conversion of medical device data from one format to another format in accordance with a preset specification. For example, this would include software that converts digital data generated by a pulse oximeter into a digital format that can be printed. Examples of medical device data systems that would be used in the home are systems that periodically collect data from glucose meters or blood pressure devices for later review by a healthcare provider.
This category is only available as an exemption from premarket clearance so long as the data set is intended for professional use and does not produce irreversible data compression.
Based on the following preamble from the proposed MDDS rule, I would suggest that through this process FDA is seriously rethinking its software policy.
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