When should manufacturers consider a mobile device a medical device?

As society moves full steam ahead with mobile devices, so has the healthcare industry with the development of new applications designed to improve health care. The applications range from teaching aids to reminders to take medication to controlling the operation of a medical device.

In mid-July, the FDA released a draft guidance document to assist manufacturers with varying questions. The Draft Guidance on Mobile Medical Applications limits the FDAs focus on mobile applications to those that have either traditionally been considered medical devices or those that affect the performance/functionality of current regulated medical devices. It is highly suggested that evaluations be performed on mobile applications to determine if they fall into the medical application category. The FDA has defined a Mobile Medical Application as those meeting the following criteria:

• Meets the definition of a device as defined in Section 201(h) of the Food Drug & Cosmetic Act. In other words the device is:

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

• Is used as an accessory to a regulated medical device

• Transforms a mobile platform into a regulated medical device

The FDA believes that mobile medical applications that meet the above criteria pose a similar potential risk to public health as currently regulated devices, if they fail to function as intended. Given this, the FDA will apply its regulatory oversight to ensure that mobile medical applications do not adversely affect public health.

Listed below are examples of mobile medical application functions that have already been deemed by the FDA as qualifying as a medical device. Those functions include:

• Viewing of medical images to perform an analysis or process for diagnosis

• Analyzing, assessing or interpreting electrocardiogram or electroencephalogram data

• Input of a patient-specific information along with reference material to automatically diagnose a disease or condition

Mobile devices will continue to evolve and advance health care well into the future. Developers of mobile applications who use a sound quality management system to create the applications will fare much better under FDA scrutiny than those that don’t.

Do you agree or disagree? Let me know!