Medical Device Apps and FDA requirements...“FDA will focus on Apps with higher levels of patient and user risk and apply discretion to Apps with lower risk potential”.
The FDA outlines a medical device as a product that is intended for use in the diagnosis, treatment, or prevention of a disease or other human health condition. If you consider the range of apps currently available (and it is estimated that up to 500m people will be using medical device apps in 2015), it is easy to see that many of these apps will fall under the scope of the FDA Medical Device regulations.
Clearly for the FDA to try to regulate every app would be a mammoth task, therefore, they have taken an approach that they do not plan to enforce regulation on every app that comes within the scope of the definition of a medical device, with the aim of focussing on Apps with the potential for a higher level of risk and will apply discretion to those apps which potentially pose low risks to users or patients.
The FDA has defined “mobile medical device apps” as apps that:
i) are intended to be used as an accessory to a regulated medical device; or
ii) are intended to transform a mobile platform into a regulated medical device.
The FDA have outlined that they only intend to regulate those medical device apps, which would pose a risk to patient safety, if they were “not to function as intended”.
Looking at i) previous, if an app connects to a regulated device in some way, it is reasonable to assume that it should be considered an extension of that product.
Looking at ii) previous , this applies to where the app is replacing a regulated medical device currently in place. Therefore, it is reasonable to see that the app will need to meet the same regulatory requirements as a standard regulated medical device.
Where the app is not performing either of the roles above, then the FDA plans to use discretion is terms of enforcing regulatory requirements.
Examples of mobile apps that FDA does not consider to be devices and with no regulatory requirements under the current laws administered by FDA:
i) Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks e.g. medical dictionaries, electronic copies of medical textbooks, medical abbreviations and definitions.
ii) Mobile apps that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received, e.g. medical flash cards with medical images, pictures, surgical training videos, interactive anatomy diagrams or videos.
iii) Mobile apps that are intended for general patient education and facilitate patient access to commonly used reference information, e.g. lists of emergency hotlines and physician/nurse advice lines.
iv) Mobile apps that automate general office operations in a health care setting
e.g. wait times and electronic check-in for hospital emergency rooms.
v) Mobile apps that are generic aids or general purpose products, e.g. maps and turn-by-turn directions to medical facilities.
Examples of mobile apps that FDA plan to apply “enforcement discretion”:
i) apps that help patients with diagnosed psychiatric conditions (e.g., depression, anxiety) maintain their behavioural coping skills by providing a “Skill of the Day” behavioural technique.
ii) apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women.
iii) apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location.
iv) apps that use video and video games to motivate patients to do their physical therapy exercises at home.
v) apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen.
Examples of mobile apps that the FDA will enforce regulatory compliance:
i) apps that use a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart (electrocardiograph or ECG).
ii) apps that use tools within the mobile platform (e.g., speaker) to produce controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
iii) apps that use an attachment to the mobile platform to measure blood glucose levels.
iv) apps that use a sensor attached to the mobile platform or tools within the mobile platform itself to record, view, or analyze eye movements for use in the diagnosis of balance disorders (i.e., nystagmograph).
The above examples are a summary of those provided by the FDA, but they give an indication of the thinking by the FDA in terms of the levels of compliance required.
If developing or referencing medical device apps you need to be aware of the regulatory requirements which may apply. Details on the FDA approach to Medical Device Apps are outlined in the FDA document “Guidance for Industry and Food and Drug Administration Staff”, “Mobile Medical Applications” document.
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