US Rep. Mike Honda (D-CA) plans to reintroduce a measure in Congress that would seek to establish a new office at the US Food and Drug Administration (FDA) dedicated to the development and oversight of mobile health technologies. Honda first introduced the measure in September 2012, late in the 112th Congress. By rule, all measures not passed during the previous congressional session must be reintroduced to be considered during the current session. The bill is intended to reduce barriers to entry for developers of mobile health applications or “apps.” FDA currently regulates mobile apps as medical devices under a framework intended to adhere to the definitions of the Federal Food, Drug, and Cosmetic Act, but Honda says the app industry does not have confidence in the regulatory framework as it now stands. REFERENCE: RAPS WEEKLY – FEB 2013
This is a very interesting topic because FDA has long struggled with what to do with mobile applications
with the birth of the Smart Phone. I have many clients that have “apps” for “that” associated with
the monitoring and patient data collection which, in turn, will be provided to a Doctor for evaluation
(sometimes even while they are skiing in Vail, Colorado). This will be a hot topic to watch related to
what FDA will end up doing with those medical devices “apps for that”.