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Most mobile medical apps avoid strict FDA oversight
The FDA has announced that it will closely regulate only those mobile medical applications that “present a greater risk to patients if they do not work as intended.”
The agency will use “enforcement discretion,” since most mobile applications, or apps, pose minimal risk to consumers, according to its announcement.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, said. “The FDA’s tailored policy protects patients while encouraging innovation.”
Jeffrey Shuren
This final guidance for developers of the mobile medical apps means that the FDA will not enforce requirements under the Federal Drug and Cosmetic Act for the majority of mobile apps.
But it will use the same “regulatory standards and risk-based approach” that it applies to other medical devices to oversee two types of apps:
- Those used as an accessory to a regulated medical device. Example: An app that allows a specific diagnosis by a health care professional viewing a medical image on a smartphone or tablet.
- Those that transform a mobile device into a regulated medical device. Example: Software that gives a smartphone the ability to detect abnormal heart rhythm or heart attack.
Since it issued draft guidance in July 2011, the FDA received more than 130 comments, most supporting the tailored approach to oversight, according to the announcement.
The FDA has cleared 40 mobile medical applications in the past 2 years and 100 during the last decade.