Food and Drug Administration draft guidance (.pdf) published July 19 seeks to regulate mobile medical applications that could compromise the functionality of other regulated medical devices. The deadline for public comment is Oct. 19.

"The FDA plans to apply its regulatory oversight only to certain types of mobile apps," notes the draft guidance. "This 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The draft guidance says the FDA will not regulate many lower-level health apps, such as Epocrates, wellness and electronic health record apps, and will instead focus on apps that perform a medical function, such as glucose-reading apps that connect to devices,

The "high-risk apps" include those that transform the mobile platform into a medical device and those that control an existing medical device's use, function or energy source.

Which of the three classes of medical device the FDA recognizes for purposes of regulation mobile medical apps will fall into likely will depend on the nature of the app, notes sister publication FierceMobileHealthcare. Electronic stethoscopes, for example, are already considered Class II devices, so any app that controls or is connected to them would likely be Class II.

Earlier FDA guidance indicated that mobile applications that store or transmit patient data are Class I apps and less risky.

For more

- read this FierceMobileHealthcare article
- download the FDA draft guidance (.pdf)
- see the FDA press release on the draft guidance

Related Articles:
VA, DoD healthcare apps prepare for next wave of features 
mHealth Coalition creates new classification system for FDA's mHealth regs
New FDA rule tackles segment of mobile health, leaves others untouched
FDA clears mobile blood pressure monitoring device