June 11, 2009

From the News Wire: iPhone Apple and FDA

From MobiHealthNews.com

Apple puts onus of FDA clearance on iPhone developers

The U.S. Food and Drug Administration has indicated in the past that under certain circumstances the iPhone may be considered a medical device and therefore regulated as one, however, as of February the FDA still hadn’t figured out exactly which circumstances those might be.

Turns out Apple isn’t waiting around for the FDA. iPhone application developer and GraniteKey COO Mike Ahmadi wrote in to point out that Apple’s iPhone developer agreement includes a special section that puts the regulatory onus, in particular the duty of ensuring FDA compliance, on the developers themselves.

Obviously this section of the agreement has become increasingly important since Apple began promoting connected peripheral devices and medical apps like LifeScan’s glucometer and AirStrip’s cardiac monitoring application at the company’s iPhone 3.0 and World Wide Developer Conference events.