The Current State of FDA Medical Device Software Regulations
Attempting to foster innovation, Congress excluded from the definition of device, software functions intended for: administrative support of a health care facility; maintaining or encouraging a healthy lifestyle without reference to any disease or condition; electronic patient records; transferring, storing, converting formats, or displaying data and results; and Clinical Decision Support Software (CDS).
The FDA has undertaken a risk-based approach to regulating software that may be considered a medical device and has attempted to clarify what is and what is not a device in several guidance documents. Of unique interest to developers are software programs that run on smartphones and other mobile communication devices, including accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. Often, these are known as mobile medical applications (MMAs). When making regulatory determinations, the FDA considers the functionality of the software. That is, if the intended use of an MMA is for the diagnosis of diseases or other conditions; the cure, mitigation, treatment, or prevention of disease; or is intended to affect the structure or any function of the body of man, the MMA is a device. The FDA applies regulatory oversight to those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device did not function as intended.
The FDA has articulated that any software intended for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition is not considered a medical device. A general wellness product is a low-risk product that has: an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or an intended use that relates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.