Medical Devices

Medical Device Data Systems

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring.

Examples of MDDS include:

  • software that stores patient data such as blood pressure readings for review at a later time;
  • software that converts digital data generated by a pulse oximeter into a format that can be printed; and
  • software that displays a previously stored electrocardiogram for a particular patient.

The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health.

On June 19 2014, the FDA issued a draft guidance "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices." Please visit the guidance for instructions on how to comment.

Page Last Updated: 06/20/2014
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