On Monday, the FDA finally released the final guidance for mobile medical apps outlining the FDA’s tailored approach to medical app regulation.
Final Guidance Focus
The FDA intends to focus on mobile medical apps that poses the greatest risk to patients that:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
The selected subset of mobile medical apps will now have to undergo the same FDA regulatory guidelines that is applied to medical devices. The agency will not regulate mobile app distributors such as the ‘iTunes App store” or the “Google Play store.”
The FDA received more than 130 public comments on the draft guidance issued in July 2011 after publicly requesting how the agency should regulate mobile health apps that collect health information and/or disease management tracking. Respondents overwhelmingly supported the FDA’s tailored, risk-based approach.
To date, the FDA has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years. (FDA gov/9/23)
To learn more, read the Mobile Medical Applications Final Guidance (PDF)