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  4. Step 5: Is the Software Function Intended For Transferring, Storing, Converting Formats, or Displaying Data and Results?
  1. Digital Health Center of Excellence

Step 5: Is the Software Function Intended For Transferring, Storing, Converting Formats, or Displaying Data and Results?

Digital Health Policy Navigator - Step 5

Intercommunication between medical devices and health information technology is facilitated by hardware and software that is typically referred to as medical device data systems (MDDS). Software functions that are solely intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results are not medical devices. The FDA has referred to these software functions as Non-Device-MDDS.

Step 5 will help determine if your MDDS software function is a device.

5.A: Is the software function SOLELY intended to transfer, store, convert formats, or display medical device data and results, including medical images, waveforms, signals, or other clinical information?

5.B: Does the software function control or alter the functions or parameters of any connected medical device?

5.C: Does the software function generate alarms or alerts or prioritize patient-related information on multi-patient displays, or provide for active patient monitoring to enable immediate clinical action?

5.D: Does the software function analyze or interpret medical device data?

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