Software in Medical Devices, by MD101 Consulting

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How to develop a smartphone App to be FDA-cleared or CE Marked? - part 1 regulations

Today I begin a new series of articles about developing (or more broadly designing) a smartphone App that is a medical device.

The very first question is:

Is your App a medical device and does it need to be CE Marked or FDA cleared ?

Short answer

That depends on the intended use of the App.

Long answer

Some mobile apps, like PACS viewers on tablets, easily qualify as medical devices. But there are many mobile apps that are at the border of medical purpose. It is usually not easy to qualify these apps as medical devices, without any further explanation about the analysis of the intended use.
The long answer relies on guidances published by the FDA or the European Commission. These guidances give many clues about the interpretation of regulations to qualify mobile apps as medical devices or not.

FDA Guidances

The FDA published in september 2013 a Guidance on Mobile Medical Applications.
This guidance clarifies a lot the qualification of mobile apps as medical devices in the USA. It gives the criteria to determine wether an app is a medical device.
The intent of the FDA is to define the Subset of mobile apps that are the focus of FDA’s regulatory oversight. Others apps outside the subset are not regulated.

However, the subset is not so easy to define, hence the FDA expects that some apps may be medical devices.
If you think your app falls into the blurred zone, you'd better contact the FDA to know what they expect of your company!

European MEDDEV

In the European Union, there is no such guidance as the FDA one. The guidance that is the closest to our need is the MEDDEV 2.1/6 - Guidance on the qualification and classification of standalone software.
It embraces a larger spectrum than the FDA guidance: standalone software. Mobile medical apps are standalone software, but standalone software include other software installed on fixed (contrary to mobile) platforms, like servers.

Unlike the FDA guidance, the MEDDEV doesn't contain specific criteria for mobile apps. It contains a decision tree which is supposed to help you to determine wether a standalone software (including your mobile apps) is a medical device.

However, you'll see that if you follow the decision tree, you will bump into the question: Is the software to be used for any of the purposes listed in Article 1(2)a of Directive 93/42/EEC. (Translation: does it fall into the definition of a medical device in the european regulation).

It's actually the answer to this question that we are seeking in a guidance. We're going in a circle!
Fortunately, there are a lot of thoughtful examples in the guidance, which help to exclude a good many of software from medical devices.

If your mobile app doesn't fit the examples of this guidance, you'd better contact your notified body (if you have one), or even the regulation authority of your country (or of your european representative) to know what they expect of your company.

To go further

Regulations of mobile medical apps in other countries like Canada, Brazil, Japan, or Australia are not as articulate as the american and (to some extent) the european regulations.
As usual, the FDA sets the tone about the regulation of medical devices but the US regulation is more stringent that regulations in other countries.

Thus, don't rely on the FDA guidance to qualify your mobile app as a medical device in other countries. Use the regulations and guidances of each country.

Next time, we'll see the development standard applied to mobile medical devices.

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