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 manufacturer" may be a healthcare facility or manufacturer that is engaged in the following activities:

  • Modifying a general purpose IT equipment/software or infrastructure for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
  • Labeling a general purpose IT equipment/software as a MDDS for purposes of interfacing to medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
  • Designing and implementing custom software or hardware for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).

The MDDS final rule became effective on April 18, 2011. All manufacturers of MDDS (including healthcare facilities that meet this definition) should be aware of the following key dates by which they are required to take specific actions:

  • May 18, 2011: Manufacturers are required to register with the FDA (90 days from Federal Register notice on February 15, 2011)
  • April 18, 2012: Manufacturers are required to implement a compliant Quality System and begin reporting adverse events (12 months from the date the rule became effective on April 18, 2011)

The following resources are provided.

AAMI

AAMI Standards and Guidance

FDA