Food and Drug Administration (FDA) has draft guidance on mobile medical applications for telemedicine health applications on smart phones.
The FDA’s draft guidance document is entitled “Mobile Medical Applications:”
FDA is issuing this draft guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). This draft guidance is not final nor is it in effect at this time
It seems odd that the FDA would reach to include mobile phones within its definition of devices. The FDA struggles to somewhat narrow the definition by explaining that "mobile medical apps" are a subset of apps, and only include an app that:
- Is used as an accessory to a regulated medical device or
- transforms a mobile platform into a regulated medical device.
Further, the FDA explains that this "narrowly-tailored approach focuses on a subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device."
FDA noted a study that indicated that 500 million smartphone users will be using health care applications in the near future. The FDA indicated that it intended to regulate those applications that create great risk when they do not work as intended. An example of a device that would be regulated is a smart phone that is converted to an ECG heart monitor.(i.e. Smartheart, a self service heart monitor).
As one law firm explains in Is Your Smart Phone An FDA-Regulated Medical Device? – FDA Announces Plans To Regulate "Mobile Medical Applications:"
The FDA views handheld computers loaded with these apps to be medical "devices" subject to extensive FDA regulation. The FDA’s draft guidance sets out its current thinking regarding when apps will trigger regulatory oversight, and how the FDA intends to enforce its regulations.
Since the FDA will be exercising its authority over industries that may be unaccustomed to FDA regulation, the affected companies are in danger of inadvertent regulatory violations. The FDA is focusing primarily on companies that write or design software for medical apps. But, depending on the circumstances, companies that manufacture or distribute the hardware also face regulatory risk. All companies in any way involved with handheld computers or their apps would be well advised to consult with regulatory counsel to determine how they may be affected by the FDA’s device regulations.
The FDA is actively seeking input into its policies. Companies that want a say in the FDA’s enforcement practices should promptly submit comments to the new "draft guidance." …
The popularity of smart phones and other handheld computers has resulted in a profusion of software applications designed to run on the handheld computers. Some of these "apps" are designed for medical purposes. The FDA’s recent draft guidance lists 34 types of apps that the FDA views as "mobile medical apps," including apps that permit the user to analyze medical data, screen patients for blood transfusions, control other medical devices, etc. According to the new draft guidance, a handheld computer loaded with such apps is a "device," as that word is used in the Food, Drug, and Cosmetics Act, and is therefore subject to the full range of device regulations….
The FDA does not view all applications with medical purposes as requiring regulatory supervision. The FDA intends to "exercise its discretion to decline to pursue enforcement actions" in connection with some classes of medical applications. Applications that will not be the subject of enforcement actions include electronic versions of medical reference works, apps relating to "maintaining general health and wellness," and apps used to perform general office functions (tailored to a medical office or otherwise). The boundary line appears to reflect whether the app is marketed for a "specific medical indication," or to analyze a specific patient.
Greg Piche of the Singularity Health Blog explains ways to differentiate what telemedicine applications the FDA will and will not regulate under its expanded definition of medical devices:
Smartphone apps existing and under development seem to fall under four main categories. First, there are the burgeoning apps that provide medical information like Medscape, Micromedex or Epocrates. Second, those that provide connectivity and access to important medical data like Fujifilm Synapse Mobility, which provides for access to 2D and 3D radiological film to treat and diagnose patients. Third, there are those that actually serve as diagnostic devices such as the Smartheart monitor. Fourth there are those apps. that provide for the storage or personal health information like Medflash personal health and wellness management. All four categories will be providing major contributions to the arc of health care quality improvement in the future.
If smartphones eventually become chips that fit inside our brains, as Ray Kurzweil predicts, will the FDA be regulating our very bodies as medical devices?
For now, FDA is justifying this jurisdictional expansion as logical extension of the legal definition of medical device. It does make the telemedicine legal landscape more challenging, as it continues to augment regulatory attention, and blur the lines between mere health information on one hand, and medical diagnosis and treatment targeted to a particular individual on the other.
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