The boom of mobile apps on smart phones clearly impacts the medical devices
industry. Doctors are eager to have the last software gadget (the app) on their
hardware gadget (the smartphone, the tablet). As a result, many apps on
Apple Store and Android Store fall into the scope of medical devices:
terminal to remotely display medical images, apps to compute doses of
medicines, an so on ... The list is long.
And gess what? These apps shall be certified before being put in the
Apple-Android stores. The FDA is clear about these "mobile medical apps" in a
draft guidance published in july 2011: "For the subset of mobile medical apps
that are subject to regulatory oversight, manufacturers must meet the
requirements associated with the applicable device classification." see the
Draft Guidance. For the CE mark, the rule is the same, mobile medical apps
fall into the category of active medical devices.
The big family of medical devices is getting more and more children. Welcome
to the baby smartphone apps!