April 10, 2014
Smartphones & Mobile Medical Apps—How Much FDA Medical Device Regulation is Required?
Smartphones and tablets have provided a plethora of new business opportunities for a number of industries, including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) for mobile medical applications. Commentators have remarked that the FDA’s guidance is complex