By Ropes & Gray LLP's Life Sciences / FDA Regulatory Practice Groups
Additional Guidance Documents Planned on Clinical Decision Support Software, Application of Quality Systems to Software, and Wireless Safety
On July 21, 2011, the Food and Drug Administration ("FDA") issued a draft guidance document describing how it intends to apply its regulatory authority to certain software applications intended for use on mobile platforms, which the agency terms "mobile medical applications" or "mobile medical apps." FDA believes that mobile medical apps pose the same or similar safety risks as currently regulated devices performing the same functions. Accordingly, a mobile medical app manufacturer, which includes a person that initiates specifications for an app, will be subject to the medical device regulation. Under the draft guidance, parties to a software development agreement can define their respective regulatory obligations by contract.
Mobile Medical Apps
The draft guidance defines a "mobile app" as a software application that runs on a mobile platform, such as an iPhone®, BlackBerry®, smart phone, or tablet computer. A mobile medical app is a mobile app that meets the definition of "device" in the Federal Food, Drug, and Cosmetic Act and is either an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.
Mobile medical apps do not include apps that:
- Are electronic medical textbooks, teaching aids, or reference materials;
- Are used as decision tools or make suggestions related to developing or maintaining general health and wellness (e.g., dietary tracking logs, exercise suggestions);
- Automate general office operations such as billing or appointments;
- Act as generic aids to assist users but are not commercially marketed for a specific medical indication (e.g., an app that uses the mobile platform as a magnifying glass but not specifically for medical purposes);
- Function as electronic health record ("EHR") or personal health record ("PHR") systems.
The draft guidance groups mobile medical apps into four main categories:
- Mobile apps that display, store, or transmit patient-specific medical device data are considered medical device data systems ("MDDS") subject to class I device requirements.
- Mobile apps that control a connected medical device are subject to the device requirements applicable to the connected device. A physical connection between the mobile platform and the device is not required.
- Mobile apps that transform the mobile platform into a medical device are subject to the device requirements applicable to the added medical device functionality. For example, an app using sensors on a mobile platform to act as an electronic stethoscope renders the app's manufacturer subject to the regulatory requirements for electronic stethoscopes.
- Mobile apps that create alarms, recommendations, or new information by analyzing or interpreting medical device data (whether electronically collected or manually entered) are subject to the device requirements of the connected device providing the data
Additional Guidance Documents Planned on Clinical Decision Support Software, Application of Quality Systems to Software, and Wireless Safety
On July 21, 2011, the Food and Drug Administration ("FDA") issued a draft guidance document describing how it intends to apply its regulatory authority to certain software applications intended for use on mobile platforms, which the agency terms "mobile medical applications" or "mobile medical apps." FDA believes that mobile medical apps pose the same or similar safety risks as currently regulated devices performing the same functions. Accordingly, a mobile medical app manufacturer, which includes a person that initiates specifications for an app, will be subject to the medical device regulation. Under the draft guidance, parties to a software development agreement can define their respective regulatory obligations by contract.
Mobile Medical Apps
The draft guidance defines a "mobile app" as a software application that runs on a mobile platform, such as an iPhone®, BlackBerry®, smart phone, or tablet computer. A mobile medical app is a mobile app that meets the definition of "device" in the Federal Food, Drug, and Cosmetic Act and is either an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.
Mobile medical apps do not include apps that:
- Are electronic medical textbooks, teaching aids, or reference materials;
- Are used as decision tools or make suggestions related to developing or maintaining general health and wellness (e.g., dietary tracking logs, exercise suggestions);
- Automate general office operations such as billing or appointments;
- Act as generic aids to assist users but are not commercially marketed for a specific medical indication (e.g., an app that uses the mobile platform as a magnifying glass but not specifically for medical purposes);
- Function as electronic health record ("EHR") or personal health record ("PHR") systems.
The draft guidance groups mobile medical apps into four main categories:
- Mobile apps that display, store, or transmit patient-specific medical device data are considered medical device data systems ("MDDS") subject to class I device requirements.
- Mobile apps that control a connected medical device are subject to the device requirements applicable to the connected device. A physical connection between the mobile platform and the device is not required.
- Mobile apps that transform the mobile platform into a medical device are subject to the device requirements applicable to the added medical device functionality. For example, an app using sensors on a mobile platform to act as an electronic stethoscope renders the app's manufacturer subject to the regulatory requirements for electronic stethoscopes.
- Mobile apps that create alarms, recommendations, or new information by analyzing or interpreting medical device data (whether electronically collected or manually entered) are subject to the device requirements of the connected device providing the data
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
