Definition Edit

Medical device data is

any electronic data that is available directly from a medical device or that was obtained originally from a medical device.[1]

Overview Edit

"[D]ata that is manually entered into a medical device is not considered medical device data. However, if manually entered data is subsequently transmitted from a medical device as electronic data it will be considered medical device data."[2]

References Edit

  1. 21 C.F.R. 880.6310(b).
  2. Food and Drug Administration, Medical Devices; Medical Device Data Systems; Final Rule, 76 Fed. Reg. 8637, 8648 (Feb. 15, 2011) (full-text).

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