Recently my wife put on a few pounds and has gotten quite lazy or as she prefers to call it, pregnant.

Jim Gaffigan

How a concept is characterized can make a big difference in the way it is welcomed – from not at all to warmly embraced. Similarly, product adoption can be influenced by the way a product is described in advertising. Regulators seem to understand this principle and their regulatory schemes often reflect it. As an example, the FDA has recently issued draft guidance to the medical device industry specifying which advertising claims are likely to trigger regulation and which are likely to exempt a medical device from FDA oversight. Draft Guidance Jan. 20, 2015.

Current Medical Device Regulations

The definition of a medical device is very broad and captures products as sophisticated as a cardiac pacemaker and as simple as a tongue depressor. For an excellent primer on FDA Medical Device Regulation, See Congressional Research Service Report, FDA Regulation of Medical Devices (June 25, 2012). With the advent of microchip-based personal and wearable devices, FDA has had to make determinations on how to regulate them. See e.g. FDA Guidance on Mobile Medical Applications (Feb. 9, 2015).

Medical device manufacturers must, among other things,

(i) register their facilities with the FDA.  21 CFR 807;

(ii) interact with the Agency prior to introducing their products to market. Id.;

(iii) follow prescribed labeling requirements. 21 CFR 801; 809.10;

(iv) follow current good manufacturing practices (cGMP). 21 CFR 820; and

(v) participate in the medical device reporting system. 21 CFR 803.

Devices that are not classified as medical devices – and certain medical devices that carry a complete exemption – are not required to adhere to these regulations.

The Proposed Guidance

The FDA’s draft guidance, General Wellness: Policy for Low Risk Devices, will not represent law — only the FDA’s current thinking on the subject. See Federal Register Notice (Jan. 20, 2015). Should it become final, however, the guidance will describe FDA’s intent to exempt medical devices that are categorized as “low risk general wellness products.”

The FDA considers elevated risk products to be ones that, among other things:

(i) are invasive;

(ii) are risky without specific controls;

(iii) raise “novel questions of usability;” or

(iv) raise “questions of biocompatibility.”

So, for example, laser instruments, implants, or devices with abrasive surfaces or mechanisms are unlikely to be treated as “low risk.” However, under the proposed guidance, devices that are low risk will be fully exempt from FDA oversight if (but only if) they are not advertised as addressing a disease state. These exempt products can, on the other hand, make claims of general wellness.

To be exempt, then, a device may claim to address weight management but not obesity, anorexia, or the like. Similarly, a device may address self-esteem but not, say, Body Dysmorphic Disorder, or may promote mental or cognitive acuity but not address Alzheimer’s or Autism. For years, FDA regulations have reflected an analogous rule to distinguish permissible advertising for nutritional supplements as opposed to drugs.

The Exception

There is one exception to the “no disease state rule.” While a low risk, general wellness device cannot claim to diagnose, prevent, cure, mitigate or treat a disease, it can be advertised as “promoting, tracking or encouraging” behaviors that, “as part of a healthy lifestyle may help reduce the risk of” certain chronic diseases or conditions. This exception is limited to chronic disease states only. For example, healthy choices that prevent myocardial infarction or acute pancreatitis are not permitted but those that involve type 2 diabetes or high blood pressure are. The FDA has even provided specific examples of acceptable phraseology:

Product ‘X’ promotes physical activity which as a part of a healthy lifestyle may help reduce the risk of high blood pressure.

Product ‘Z’ tracks activity sleep patterns and promotes healthy sleep habits which as part of a healthy lifestyle may help reduce the risk of” chronic inflammatory disease.

The Potential Effect: One Example

Consumer Physics, Inc. is preparing to launch SCiO, its much-anticipated hand-held, IR spectroscopic-based sensor. This device will apparently read and analyze the molecular composition of an object. For example, the SCiO is said to be able to detect the chemical composition of a drug or supplement and, using cloud-based analytics, help a patient “authenticate medication.” This could potentially allow consumers to identify and avoid counterfeit drugs.

Given its apparent capabilities, a device like the SCiO could be used for a wide range of health-related purposes – some regulated and some not. For example, Consumer Physics advertises the SCiO as able to help a shopper “get nutritional facts” about the foods they purchase and adds that it will soon be able to determine the “ripeness” of foods.

Such claims seem unlikely to provoke FDA regulation. However, promoting the same device as capable of detecting the presence of allergens in food could likely be seen as too close to the line of “mitigating or preventing the acute onset of a disease” thereby triggering FDA regulation. Notably, the SCiO website and instructions both contain this advisory:

Please Note – SCiO is not a medical device and should not be used to treat or prevent medical conditions such as allergies.

The draft guidance, General Wellness: Policy for Low Risk Devices, is open for comment until April 20, 2015. We will continue to follow its progress and implementation.