Whatever the various laws and guidances might say, I would ask more broadly whether the community sees any reason to approach the question of whether a device is a medical device or a health/wellness device any differently for a mobile app versus software-driven device, versus a device that has no software?
Off the top of my head, I can't see any reason to approach this question differently based on the technology of the device, since the answer seems to hinge entirely on intended use, doesn't it?
What FDA does about enforcement is a different matter.
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 22-Jan-2017 15:08
From: Timothy Kline
Subject: Triggers Utilized - Mobile Healthy Apps to Mobile Medical Apps
I am interested in obtaining community opinion on common triggers utilized when assessing if a mobile application is merely a health/wellness app versus a mobile medical app.
I have read through the guidance from 09, February 2015 and of course the language in the Century Cures Acts basically laying out enforcement (of lack thereof for health & wellness apps).
However, I am curious what common triggers/questions (ie calculations are contained within the app but include no PII, personally identifiable info,) the community has come across when making the decision. I have my opinions but am hoping to use this forum to get multiple perspectives on the subject.
Thanks,
------------------------------
Timothy Kline, Ph.D., RAC
Senior Associate Regulatory Affairs
------------------------------