FDA Issues Final Rule on Medical Device Data Systems


On February 15, 2011, the United States Food and Drug Administration (FDA) issued a final rule formally “reclassifying” Medical Device Data Systems (MDDSs) from Class III into Class I. As Class I, 510(k)-exempt devices, MDDSs will not be subject to FDA premarket review or clearance. MDDS manufacturers will be required to register as medical device manufacturers and list their commercially distributed MDDS devices with the FDA by April 18, 2011. Manufacturers also must establish compliant quality systems for the design, manufacturing, and validation of their MDDSs, as well as adverse event reporting procedures, by April 17, 2012.

Medical Device Data Systems

A Medical Device Data System is a new category of medical device that acts as a communication conduit for electronic data obtained from other medical devices. An MDDS may be used for the electronic transfer, storage, conversion, or display of data. It may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. MDDSs do not include devices that control or alter the functions of any connected medical devices or that are intended to be used in connection with active patient monitoring. Examples of MDDSs include devices that collect and store data from glucose meters for future use or that transfer lab results for future use at a nursing station.

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