In July, 2011, the US Food and Drug Administration (FDA) issued a proposal for guidelines relating to mobile medical applications. This sector of the medical device industry is growing exponentially and the FDA determined it was necessary to issue guidance regarding the manufacture and development of some of these apps. After comment by the public and revisions by the FDA, final guidance was issued on September 25, 2013.
The FDA regulates medical devices for their risk to a patient’s safety. It intends to continue this philosophy in its regulation of mobile medical device apps available for medical providers and consumers.
The FDA’s guidance instructs medical device app manufacturers that “when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.” The FDA set out examples and explained further what apps it would and would not regulate at this time.
What the FDA will regulate
The FDA will regulate any mobile medical app which performs active patient monitoring, such as apps which regulate the inflation and deflation of a blood pressure cuff. It will also regulate mobile medical apps that act as an attachment to a medical device that is already regulated by the FDA, such as an attachment to a blood glucose reader or an attachment to a device that monitors sleep apnea. Lastly, the FDA intends to regulate any mobile medical apps which perform patient-specific analysis and patient-specific diagnosis or treatment. This would include apps which would use patient specific information to determine specific treatment plans, such as radiation dosages or therapies.
The FDA intends to regulate these devices because these are the types of devices that pose the same or similar potential risks to the public health as currently regulated devices if they fail to function as intended. The mobile medical app manufacturer will be required to follow the same guidelines and procedures for approval as a medical device manufacturer. The mobile medical apps will be classified in the same class as the medical device it intends to aid in the function of or that it will perform a similar function to.
What the FDA will not regulate
The FDA will not regulate those mobile medical apps that simply act as a tool to organize and track health information, transmit easily accessible information related to conditions and treatments or apps which perform simple calculations routinely used in clinical practice.
What this means for consumers
For consumers this is good news. The FDA is now recommending and requiring that mobile medical apps meet the same safety and efficacy standards required by medical device manufacturers. This will allow consumers and medical care providers who use these apps to know that the mobile medical app meets the safety and efficacy requirements of the FDA and that the manufacturers are subject to the same reporting requirements for failures, adverse events and recalls as medical device manufacturers. Those apps that are intended to perform active monitoring of a patient’s condition or that are intended to aid the practitioner in the diagnosis and treatment of a patient’s condition will have gone through a review process before being allowed on the market for use. Unfortunately this is not a guarantee that some apps will not have design problems or possibly be subject to safety recalls.
You can read more specifics about the FDA’s regulatory requirements by clicking here: Mobile Medical Apps – Guidance for FDA