Final medical app guidance issued by FDA
The FDA has issued its final guidance for mobile medical application developers, committing to limited regulation for most health and wellness apps while applying risk-based standards to diagnostic and quasi-medical device apps. The FDA will implement “enforcement discretion,” under the Federal Food, Drug & Cosmetic Act, for the majority of mobile apps “as they pose minimal risk to consumers,” the agency announced in a recent press release. Included are apps helping patients self-manage their disease or conditions “without providing specific treatment or treatment suggestions,” such as for tracking exercise and diet, automating health tasks or communicating with providers via EMRs.
The FDA will focus “on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended,” for example apps designed to detect melanoma. The FDA is generally categorizing medical apps to be regulated into those intended for use as a medical device accessory (such as an app allowing clinicians to view medical images on a smartphone or tablet) and those using mobile platforms as a medical device (i.e. an app that enables a smartphone as an ECG monitor).
“Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, announced. “The FDA’s tailored policy protects patients while encouraging innovation,” he added. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
The HHS agency has already approved 100 mobile medical applications over the past decade, about 40 of these during the past two years. Some of the more complex, potentially high-risk apps the FDA is going to regulate are among those currently on the market; like apps using smartphone technology to detect abnormal cardiac rhythms or act as an ultrasound device that will be used by patients as well as clinicians. The FDA said comments on the draft guidance had been received with industry representatives, providers and other stakeholders “overwhelmingly” supporting the risk-based approach already applied to medical devices.