Are you developing a mobile app? Be careful, the FDA may consider it a medical device

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Is your App an app or a medical device?

Mobile Medical Devices – FDA directives on Connected Health

The Food and Drug Administration is encouraging the use of innovation when it comes to improving patient healthcare. One area that is experiencing growth is medical devices associated with mobile devices like phones and tablets. The FDA has issued guidance on mobile medical applications on the regulation of medical devices but here is a summary of the document.

The FDA is does not consider the device manufacturer (e.g., Apple, Samsung, Nokia, etc.) as a medical device manufacturer. Similarly, the application distribution technology is exempt as well. This means that the Mac app store or iTunes, Google Play, etc., do not need to register with the FDA. This leaves the app developer as the sole entity to register the medical device.

Not all mobile apps are medical devices, though. Here is a list of attributes that the FDA considers key in defining a mobile medical device. This is not a comprehensive list. More data is available here.

Mobile apps that transform a mobile platform into a regulated medical device is a mobile medical app

• For example, if the app uses a sensor or lead that is connected to a mobile device to measure and display an electrical signal generated by the human body, for example, an electrocardiograph or EEG. Or if the speaker of the device is used to amplify a heartbeat like a stethoscope or to produce tones for audiology.

• If the app uses the accelerometer or LED light to monitor physiological parameters. • If the app has an attachment that measures a specific parameter of the body (oxygen saturation, glucose levels, etc.)

• If the app has an attachment that treats a condition (wrinkles or acne, etc.)

• If the app logs data about the human body (e.g., blood type) and sends the data to a facility for analysis

Mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source is a mobile medical app

• If the app controls an infusion pump, a neuromuscular stimulator, cochlear implant, etc.

Mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device is a mobile medical app

• For example, devices that connect to a nursing central station, cardiac monitor, or maternal uterine contractions, etc. to display remotely acquired data.

Here is a list of app characteristics that the FDA has indicated that it may classify the app as a mobile medical device (at the enforcement discretion of the FDA)

• Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder, depression, anxiety, obsessive compulsive disorder)

• Mobile apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction

• Mobile apps that use GPS location information to alert asthmatics of environmental conditions

• Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home

• Mobile 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 in the literature and a summary of what type of interaction was reported

• Mobile apps that help asthmatics track inhaler usage

• Mobile apps that prompt the user to manually enter symptomatic, behavioral or environmental information, the specifics of which are pre-defined by a health care provider, and store the information for later review
• Mobile apps that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening

• Mobile apps that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider

• Mobile apps that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most appropriate to their needs

• Mobile apps that record the clinical conversation a clinician has with a patient and sends it (or a link) to the patient to access after the visit

• Mobile apps that are intended to allow a user to initiate a pre-specified nurse call or emergency call

• Mobile apps that enable a patient or caregiver to create and send an alert or general emergency notification to first responders

• Mobile apps that keep track of medications and provide user-configured reminders for improved medication adherence

• Mobile apps that provide patients a portal into their own health information, such as access to information captured during a previous clinical visit or historical trending and comparison of vital signs (e.g., body temperature, heart rate, blood pressure, or respiratory rate)

• Mobile apps that aggregate and display trends in personal health incidents

• Mobile apps that allow a user to collect blood pressure data and share this data, and track it

• Mobile apps that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness


And to round out the list, the FDA does not consider these to be a mobile medical apps

not a mobile medical appScreen Shot 2014-03-31 at 11.10.20 AM

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