New Mobile Health Application Guidelines: The Regulatory Impact on Developers

 

By Natalie DeMasi, Research Analyst

If it looks like a medical device and it works like a medical device, it’s probably a medical device.

App developers, the wait is over!  The FDA has finally released its guidance on mobile medical applications.  The guidance describes the types of apps that are covered under FDA oversight and those left to the discretion of app developers.

Apps designed for patient monitoring and support typically fall outside of FDA oversight.  These include apps that:

• Help patients monitor their disease
• Keep track of health information, including access to electronic medical record
• Help patients find and contact healthcare providers
• Provide general health information to patients

FDA oversight will apply to apps that the FDA defines as medical devices under 201(h) of the Federal Food, Drug and Cosmetic Act.  In sum, if the mobile app functions like a medical device and could pose a serious risk should it malfunction, it is considered a medical mobile app.  These include mobile apps that:

• Modify a mobile platform (i.e. smartphone, tablet or portable computer) into a regulated medical device
• Adjust settings, functions or operations of an existing medical device via either direct or wireless connection
• Control or transfer patient-specific medical device data

Devices that fall into these categories need to follow the standard regulations for an equivalent medical device.  For example, these guidelines require companies that develop mobile medical apps to annually register their applications.  Mobile medical manufacturers should also follow good manufacturing practices (GMPs) similar to those already practiced in the medical device field.  Most mobile medical app manufacturers — those with Class 1 and Class 2 medical devices — will have to submit 510(k).  Should the industry ever develop a mobile app that sustains life, these Class 3 devices will require premarket approval (PMA) prior to launch.