INTENDED USE OF CLINICAL REACH

Per FDA guidance as of February 9, 2015, CLINICAL REACH™ by Parallel 6 is considered a Mobile Medical App and a Medical Device Data System (MDDS).

THE INTENDED USE FOR CLINICAL REACH IS:

  • To be used as a helpful self-directed reminder tool for medication compliance and clinical visits
  • To facilitate supplemental clinical care, by coaching or prompting for pre-determined medication dosing schedules or to manually enter symptomatic, behavioral or environmental information
  • To enhance patient communication with videoconferencing portals, pictures
  • To transfer, store, convert format, and display medical device data, without controlling or altering the functions or parameters of any connected medical device

CLINICAL REACH IS NOT INTENDED:

  • To transform mobile platforms into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.
  • To control the functions or parameters of any connected medical device
  • For active patient monitoring, primary diagnosis or treatment decisions 

 

References:

FDA Guidance for Medical Device Data Systems (MDDS) as of February 9, 2015
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm401996.pdf

FDA Guidance for Mobile Medical Applications as of February 9, 2015
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf