Should "general wellness" products like weight management tools, fitness trackers or relaxation helpers be regulated as de facto medical devices? The US Food and Drug Administration (FDA) doesn't think so, much to the relief of manufacturers of general wellness products.
In recent years, FDA has struggled to regulate new types of products which straddle the line between healthcare product (i.e. a medical device) and general consumer wellness (not regulated by FDA).
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), a medical device is defined as:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
- 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
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of 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 any of its primary intended purposes
For most medical devices, it's relatively easy to determine if a device should be regulated under the FD&C Act. Pacemakers, for example, are clearly regulated under the act, because it affects the structure of the body. An in vitro diagnostic product is clearly a device, because it is used in the diagnosis of disease and other conditions.
But for other classes of devices, including general wellness products, the distinction can be a little bit less clear. For example, consider a smartphone application which suggests a specific diet. If the program is targeted at a "general" audience (i.e. non-disease specific), it likely wouldn't fall under the FD&C Act, because it wouldn't be "intended for use in the … cure, mitigation, treatment or prevention of disease."
But suppose the application was specifically intended for patients with diabetes, and recommended specific food choices intended to help patients with diabetes control their blood sugar? Even if the application recommended the same food as before, when it was targeted toward a general audience, the program would technically be a medical device since it would be intended to mitigate, treat or prevent a specific disease (diabetes).
FDA's New Approach
The lack of regulatory clarity in this particular area had concerned some product developers, who said compliance with FDA quality system regulations (QSRs) and other federal regulations would be too difficult for most software developers.
So in January 2015, FDA released a new draft guidance document, General Wellness: Policy for Low Risk Devices, in which the regulator exempted most general wellness products from federal regulatory requirements, including pre-market review and post-market surveillance requirements.
"[FDA] does not intend to examine low risk general wellness products to determine whether they are devices [under federal law] … or whether they comply with the premarket review and post-market regulatory requirements for devices," FDA explained in the document.
The policy was largely expected by industry after FDA issued several other guidance documents related to health software, medical device data systems and device accessories. All three guidance documents took a hands-off approach to regulation reflective of a "least-burdensome" approach.
Under the general wellness guidance, FDA said it would not regulate products so long as they subjected patients to a "very low risk" of harm and were aimed at benefiting "general" conditions, such as stress, weight, self-esteem, sleep or sexual function.
However, if a device or an app claimed to treat or diagnose obesity, anorexia, autism, anxiety, erectile dysfunction or any other specific disease or condition, it would fall afoul of FDA's policy and be regulated as a medical device.
The approach is similar in many respects to FDA's approach toward dietary supplements.
FDA's approach is now earning rave reviews from several general wellness industry proponents.
In comments submitted to FDA's federal docket and made public on 18 June 2014, several groups weighed in on the guidance, calling it a good first step.
One group, the Consumer Electronics Association (CEA), said it "applauds the efforts taken by FDA to reduce the regulatory burdens for low risk products that promote a healthy lifestyle."
"FDA's guidance documents, such as this one, have the potential to enhance healthcare in the United States by providing clarity on FDA's current policies," added the Telecommunications Industry Association (TIA), which commended FDA on its approach.
Another manufacturer, Samsung, said FDA had done an "excellent job of clarifying the FDA's current regulatory policies and practices."
Additional Clarifications Wanted
Despite the praise, several groups said they hoped the final version of FDA's guidance could further clarify several aspects, and even add exemptions for particular products.
For example, CEA said it wanted clarification to see if mood and emotional wellness, diet-tracking (specifically sodium or sugar intake), smoking and alcohol cessation, and injury prevention products would fall under FDA's guidance. CEA also said it wanted to know if personal sound amplification products—the subject of FDA guidance in 2013—might fall under the guidance as well.
Both CEA and TIA said they hoped FDA might also clarify its definition of "low risk" products—a definition which forms the basis of FDA's guidance. Both groups said they had questions regarding the guidance's definition of the term "invasiveness," "biocompatibility" and "novel questions."
Samsung, meanwhile, said it hoped FDA could add heart rate monitors and blood oxygen saturation monitors to the guidance as examples of general wellness products.
FDA Federal Docket