FDA issues final guidance on mobile medical apps

October 18, 2013

FDA issued final guidance for developers of mobile medical applications (“apps”) that outlines FDA’s tailored approach to mobile apps.

FDA issued final guidance for developers of mobile medical applications (“apps”) that outlines FDA’s tailored approach to mobile apps.

The finalized FDA guidance on mobile medical apps focuses on 2 areas: 1) apps that, due to their functionality and intended use, turn the mobile device into a medical device and 2) apps that act as accessories to currently regulated medical devices, according to Kyle Peterson, director, regulatory & corporate affairs for Calgary Scientific, Calgary, Canada.

Currently, mobile medical apps can diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a patient with insulin-dependent diabetes.

FDA intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work like they are supposed to.

FDA is focusing its oversight on mobile medical apps that: 

· Are intended to be used as an accessory to a regulated medical device-or example, an application that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system 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 machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

The agency does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the ‘iTunes App store” or the “Google Play store.”

FDA received more than 130 comments on the draft guidance issued in July 2011. Respondents overwhelmingly supported FDA’s tailored, risk-based approach. FDA has cleared about 100 mobile medical applications over the past 10 years; about 40 of those were cleared in the past 2 years.

“[Managed care and hospital decision-makers] should examine any mobile medical apps they currently use to evaluate whether they are for diagnostic use or remotely connect to another medical device [eg, heart monitor],” Peterson told Formulary.

“Such apps will be regulated under the new guidance and they should know whether the app they use has passed through FDA review. If they are using an app that appears to fall into the regulated category and has not passed FDA review, at a minimum, they should be questioning the author to see if they agree that their app is regulated and what their plans are for compliance,” Peterson continued. “If the app they’re using impacts patient diagnosis, management or treatment, and they are in doubt about its compliance, they can contact FDA for clarification.”

For more information:

·       Mobile Medical Applications Final Guidance

·       Consumer Update: Keeping Up with Progress in Mobile Medical Apps

·       Mobile Medical Applications Web Page