It’s been predicted that mobile devices are poised to overtake traditional desktop computers as the channel of choice for accessing the Internet. With the variety of devices and their computing power increasing rapidly, growing numbers of patients and healthcare professionals are turning to their laptops, tablets, and smartphones for medical information as well as health and wellness management.
Because computer-based technology has evolved and grown exponentially over the past few years, the FDA has had trouble keeping up with advances in computer and software products and their use as – and in – medical devices. The agency initially prepared a general policy statement in 1989 entitled FDA Policy for the Regulation of Computer Products (which became known as simply the Draft Software Policy), but withdrew it in 2005 after determining it did not adequately address the rapid technology evolution.
Eager to tackle the challenge again, the FDA recently released an updated policy statement entitled, Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff. In it, the agency has classified certain types of apps that meet the definition of a device and identified specific regulatory requirements that apply to them and their manufacturers. In general, software devices include products that feature one or more software components, parts, or accessories, such as ECG systems. With regard to the mobile market, mobile medical apps are classified as medical devices that happen to be mobile software applications, meeting the definition of a medical device. As such, mobile medical apps are an accessory to a regulated medical device or transform a mobile platform (for example, a smartphone) into a regulated medical device.
Mobile medical apps can be divided into two main categories. One is consumer-oriented — apps that enable people to manage their own health and wellness; for example, by monitoring their calorie intake or providing information about the effects of certain medicines. The other helps medical professionals improve and facilitate patient care.
The FDA is applying the same risk-based approach they use for other medical devices to assure their safety and effectiveness, as outlined in the recently released. This document contains good examples of how the agency might regulate certain Class II and Class III mobile medical apps, as well as examples of mobile apps the agency does not consider medical devices.
To be clear, the new FDA policy does not:
- regulate the sale or general consumer use of smartphones or tablets
- consider entities that exclusively distribute mobile apps, such as iTunes or Google Play, to be medical device manufacturers
- consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by the FDA
Still, it’s not a bad idea if you’re an app developer to contact the FDA – or a regulatory consultant such as us — if you have any questions about your mobile app, its level of risk, and whether a premarket application is required.