INTENDED USE OF CLINICAL6
Per FDA guidance as of February 9, 2015, CLINICAL6™ by Parallel 6 is considered a Mobile Medical App and a Medical Device Data System (MDDS).
THE INTENDED USE FOR CLINICAL6 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
CLINICAL6 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
FDA Guidance for Medical Device Data Systems (MDDS) as of February 9, 2015
FDA Guidance for Mobile Medical Applications as of February 9, 2015