The U.S. government is holding a workshop on “Mobile Medical Applications” at which it seeks to obtain comment on how to approach accessories and particularly mobile medical applications that are accessories to other medical devices, as well as standalone software providing clinical decision support.
The Food and Drug Administration (FDA) announced the workshop in a Federal Register notice dated Aug. 12, 2011. The workshop is scheduled for Sept. 12 and 13, 2011 in Silver Spring, Md. the FDA says.
The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment on the FDA’s draft guidance document entitled “Mobile Medical Applications,'” which was issued July 12, 2011, the FDA says. The draft guidance is needed because of “the rapid expansion and broad applicability of mobile applications (mobile apps),” the FDA seeks “to clarify the types of mobile apps to which the FDA intends to apply its authority.”
Currently, the FDA intends to apply its regulatory requirements to a subset of mobile apps that the agency has designated “mobile medical applications (mobile medical apps)” For purposes of the draft guidance and the public workshop discussion, a “mobile medical app” is a mobile application that is built with or consists of computer and/or software components, the FDA says. That includes an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man” or “intended to affect the structure or any function of the body of man or other animals.” Such a device can be used as an accessory to a regulated medical device, or transforms a mobile platform into a regulated medical device, the agency says.
That narrowly tailored approach focuses on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device, the FDA says. In addition, while some mobile apps do not meet the definition of a mobile medical app, those devices may still meet the definition of such a device, and the FDA intends to exercise enforcement discretion towards those mobile apps, it says.
For more information on the workshop, click here.
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