Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn’t.
After more than two years since the FDA first published its draft guidance on how it regulates mobile medical applications, the agency announced this morning that it had published its final guidance on the regulation of mobile medical apps. Notably, the FDA published its final guidance document just before the end of September, which would have marked the end of the agency’s fiscal year. At the congressional hearings earlier this year, the FDA more or less promised to get the guidance out before the end of its fiscal year.
The overall message from the FDA has not changed much since it first published its draft guidance — the final document is nonbinding and explanatory in nature. It also focuses on a small subset of medical apps “that present a greater risk to patients if they do not work as intended,” the agency wrote in a press release.
The two broad categories of apps that the FDA regulates, according to the final guidance, are:
1. 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
2. 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.
As it noted during Congressional hearings earlier this year, the FDA has already cleared about 100 mobile medical applications over the course of the last 10 years or so — about 40 FDA-cleared apps received their clearance in the past two years, according to the FDA. As a former FDA director once advised in 2011, at least a few dozen developers didn’t wait for the final guidance document to drop to create their wares.
Shortly before the FDA published its draft guidance document in mid- to late 2011, the Federal Trade Commission moved to remove two health-related apps from Apple’s AppStore and Google’s Play store, then called the Android Market. Both the apps were paid apps that promised to help cure user’s acne via a blue light emitted from their phones’ screens. While these apps were not found to be necessarily harmful to the user’s health, the FTC argued they were based on specious claims.
The FDA also published an important guidance document for mobile health devicemakers — the hardware side of the industry — in August. The guidance on device interoperability had been in the works even longer than the mobile medical apps document.
For more on regulated apps, check out our report: 75 FDA-cleared Mobile Medical Apps.