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Medical device data system

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Definition Edit

A medical device data system (MDDS) is

a device that is intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted, or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring.[1]
(1) . . . a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
(i) The electronic transfer of medical device data;
(ii) The electronic storage of medical device data;
(iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or
(iv) The electronic display of medical device data.
(2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.[2]

References Edit

  1. U.S. Food and Drug Administration, Medical Devices; Medical Device Data Systems; Final Rule, 21 C.F.R. Part 880 (Feb. 15, 2011).
  2. 21 C.F.R. 880.6310.

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