[BlogPost@KevinMD.com] Why mobile health devices need FDA oversight

[JaniceFlahiff]

April 15, 2012
http://www.kevinmd.com/blog/2012/04/mobile-health-devices-fda-oversight.html

Excerpt
"advisories or recalls affect an extremely small segment of most
devices. Device advisories and recalls will occur with mHealth
technologies as well. These devices are not 100% immune to defects.
Most defects when they do occur, affect components which are not
critical. Some will affect direct to consumer types of devices, which
would translate into a voucher for refund or replacement. Others,
however, will be of a potentially more significant nature, possibly
affecting the accuracy of remote patient monitoring data (though in
over 12 years of remote patient monitoring of ICDs no significant
defects have been seen regarding the monitoring capabilities itself)
or technical glitches possibly resulting in wrong advice being given.

It is when we get into the more sci-fi types of technologies where
defects may affect patients more. Implantable monitors, drug or DNA
transporters or monitors injected into the bloodstream, or artificial
type skin with sensors, where an advisory or recall approaches new
territory. The FDA is moving to tighten post-market surveillance of
implantable devices, in part with the institution of a unique device
identifier (UDI) system. I believe that mHealth products will be able
to be tracked much easier than by UDIs by virtue of their own
technologies’ tools. Quality control of mHealth should not be any
different from other medical devices, and should therefore fall under
the auspices of the FDA."