On July 29, 2016, the Food and Drug Administration (FDA) issued final guidance on the regulatory status of “low risk” “general wellness” devices. The non-binding guidance provides a degree of certainty to manufacturers of popular devices such as FitBit, the Apple Watch, and various health ‘apps,’ whose products arguably fall within the Food, Drug, and Cosmetic Act’s definition of medical “device.”
Pursuant to the final guidance, a product will not be regulated as a medical device if it (1) is intended solely for “general wellness,” and (2) presents a “low risk” to the safety of users and third parties. “General welfare” falls into two categories: “maintaining or encouraging a general state of health or a healthy activity;” or, reducing the risk or impact of certain chronic diseases or conditions through promoting a healthy lifestyle where it is “understood and accepted” that healthy lifestyle choices play a role in health outcomes.
For the first category, the FDA provided an exhaustive list of purposes: weight management, physical fitness, relaxation, mental acuity, self-esteem, sleep management, and sexual function. For the second, the FDA gave examples, such as “claims to promote or maintain a healthy weight” and “claims to improve general mobility” in the mobility-impaired. The agency explicitly excluded products from the guidance that claim to “treat or diagnose” medical conditions such as obesity, anorexia, autism, or erectile dysfunction.
The FDA also defined “low risk” products as not invasive, implanted, or otherwise dangerous to the consumer or third parties in the absence of regulatory controls. Examples of “general wellness” products that are not “low risk” include sunlamps, skin-rejuvenation lasers, neurostimulation electrodes, and athletic-performance ‘apps’ that rely on blood samples.
The FDA currently regulates medical-support software and wearable devices that meet the definition of “device” under section 201(h) of the Food, Drug, and Cosmetic Act. Manufacturers must submit devices to the FDA’s premarket or 510k approval processes and thereafter conform to applicable FDA regulations. The FDA’s final guidance provides manufacturers of “low risk” and “general wellness” health products with a non-binding safe harbor from FDA regulation. Innovative manufacturers thereby avoid the financial and time costs associated with obtaining FDA approval. But this non-binding safe harbor gives rise to additional uncertainties and potential for litigation. Manufacturers that overestimate the safety of their products will face products-liability actions without the benefit of the medical device amendment’s express preemption provision or the doctrine of implied preemption. And whereas manufacturers of regulated medical devices have a duty to warn only the learned intermediary in most states, manufacturers of “general wellness” products are charged with a duty to warn the ultimate consumer. Lastly, absent careful review, manufacturers of “low risk” products employing advertising or promotional materials that err beyond “general wellness” and claim products treat or diagnose ailments or illnesses could be subject to FDA review and enforcement action.
Keywords: litigation, mass torts, medical devices, FDA regulation, premarket approval, 510k approval