The FDA publishes guidance on mobile medical apps
14th October 2013 by Claire Govier
After two years of discussions and consultations, the US Food and Drug Administration (FDA) has issued their Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. As suggested by draft versions of the document, there is a clear separation between apps that will be monitored and those that will be less scrutinised.
So what does the FDA classify as a mobile medical app? Perhaps the best way to define is to discuss what is not likely to undergo review. Apps that are electronic versions of textbooks or educational tools for physicians, such as interactive anatomy diagrams or surgical training videos are not included.
Apps designed to help patients keep track of their condition or find out more general information about their condition (not including treatment approaches) and where to find information about relevant clinical trials or places to seek treatment escape scrutiny.
Also, general business tools, such as apps for billing codes, insurance claim information, appointment reminders and management of staff and beds are unlikely to attract the attention of the FDA.
The definition ‘mobile medical apps’ helps explain the criteria for those that will be reviewed in line with the Federal Food, Drug and Cosmetic (FD&C) Act. Any app that acts as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device will be examined. This includes apps that can be used to perform diagnostic functions such as cardiac function tests, blood oxygen or glucose testing or control medical devices such as infusion pumps.
Apps that are deemed to pose a lower risk to the public may be subject to a review at the discretion of the FDA. These include apps that help patients manage their condition, either by providing prompts to monitor behaviour or encourage compliance.
If there is functionality to review signs and symptoms at a later date with a healthcare professional or to monitor possible drug interactions built within the app, this may also lead to scrutiny.
The number of apps reviewed by the FDA has rocketed in recent years; in the past decade, over 100 apps have undergone evaluation, with around 40 being approved within the last two years.
With the increasing prevalence of smart technologies, the FDA have adopted a tailored approach that aims to ensure patient safety without stifling innovation.