In a move that's sure to be watched closely by medical regulators worldwide, America's Food & Drug Administration (FDA) has issued its final regulatory guidance on regulating medical apps running on smartphones.
The announcement formalises a draft guidance issued in July, the culmination of a long process under which 100 apps have already been cleared over the last decade.
The FDA isn't taking aim at the entire world of medical or near-medical apps, only those which “perform the same functions as traditional medical devices”. In particular its concern is apps that might pose a risk to the patient if they lock up, crash, or simply don't work as intended.
The two examples highlighted by the administration are apps that are built to run as an accessory to regulated medical devices (for example, as diagnostic aids), or apps that try to replicate regulated devices like ECGs to detect heart attacks or abnormal heart rhythms.
Its guidance is designed to distinguish high-risk from low-risk apps, and highlights how the unwary or lazy app maker might find itself caught by surprise by an apparently-innocent app that turns on an LED on the phone:
“If, however, through marketing, labeling, and the circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for use as a light source for doctors to examine patients, then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope”.
However, the guidance reiterates, “we intend to apply this oversight authority only to those mobile apps whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended”.
The regulation won't apply to app stores that merely host the apps. ®
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