On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance. Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight.
On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance (Proposed Guidance). Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight. As discussed in our Draft Guidance commentary, the Final Guidance is the latest in a series of efforts in which the agency has attempted to clarify the regulatory requirements for health information technology products.
What is a general wellness product?
For a product to be classified as a general wellness product, it must: (1) be intended only for general wellness use, and (2) present low risk to the safety of users and other persons. Products that fulfill both requirements may include: exercise equipment, audio recordings, video games, software programs and other products commonly available from retail establishments. (1) Must be intended only for general wellness use
In the Final Guidance, FDA retains its position that a general wellness product’s intended use must fall within one of two categories:
The first category of intended uses relates to maintaining or encouraging a general state of health or a healthy activity without referencing any particular disease or condition. Claims of this nature include those related to weight management, physical fitness (e.g., items intended for recreational use), mental acuity, relaxation or stress management, self-esteem (e.g., cosmetic items intended to boost self-esteem), sleep management and sexual function. The agency also added “claims to enhance learning capacity” as an example of an intended use that could fall within this category.
The second category of intended uses includes those for the promotion, tracking or encouragement of healthy lifestyle choices that may help—“reduce the risk of” or “living well with”—certain chronic diseases or conditions (e.g., heart disease, hypertension, type 2 diabetes). The claim that a particular lifestyle choice affects a specific health outcome should be “generally accepted.” General acceptance may be established through peer-reviewed scientific publications or in official statements made by healthcare professional organizations (e.g., the American Heart Association, American Association of Clinical Endocrinologists). The acceptance of statements by healthcare professional organizations is a notable change from the Proposed Guidance, which identified “peer-reviewed publications” as the sole means of demonstrating “general acceptance” of a claimed association between a particular healthy lifestyle choice and a specific health outcome.
Notably, in the Final Guidance, the FDA added three additional examples of intended uses that would fall within this category:
Software Product U coaches breathing techniques and relaxation skills, which, as part of a healthy lifestyle, may help living well with migraine headaches.
Software Product V tracks and records your sleep, work and exercise routine which, as part of a healthy lifestyle, may help living well with anxiety.
Product W promotes making healthy lifestyle choices such as getting enough sleep, eating a balanced diet and maintaining a healthy weight, which may help living well with type 2 diabetes.
(2) Must present low risk to the safety of users and other persons
Products are low risk if they: (1) are not invasive, (2) are not implanted, and (3) do not involve an intervention or technology that requires regulatory controls to protect against risk to users or others if specific regulatory controls are not applied. (These criteria represent a departure from the criteria set forth in the Proposed Guidance, which also required an analysis of the product’s usability and biocompatibility, and focused solely on the safety risk to the user.) If the product meets any of the three factors, it is not a low risk general wellness product and is not covered by the Final Guidance.
In addition to sunlamps, implants and lasers, the FDA added two examples of products that fail to meet the “low risk” requirement:
A neurostimulation product that claims to improve memory is not low risk because of the risks to a user’s safety from electrical stimulation.
A product that claims to enhance a user’s athletic performance by providing suggestions based on the results of relative lactic acid testing, when the product uses venipuncture to obtain the blood samples needed for testing. The product is not low risk because: it is invasive (e.g., obtains blood samples by piercing the skin), and involves an intervention that may pose a risk to the safety of the user and other persons if specific regulatory controls are not applied (e.g., venipuncture may pose a risk of infection transmission).
In assessing whether a product is “low risk,” the FDA also recommends determining whether particular types of products that share common qualities with the product in question, are actively regulated by FDA, which may be helpful for the purposes of categorizing an item that is not explicitly addressed in the Final Guidance.
On page nine, the Final Guidance provides a user-friendly decision framework, which summarizes the above-described process for determining whether an item may be classified as a low risk general wellness product.
The Final Guidance reflects a more flexible regulatory approach for general health and wellness devices and associated marketed claims. With the publication of the Final Guidance, manufacturers and developers have additional examples and regulatory factors to help them to tailor their design and marketing strategies to risk profiles of general wellness products. Though helpful, the Final Guidance does not address FDA’s thinking in other areas. Most notably, the Final Guidance does not address claims development and substantiation issues with respect to the regulatory requirements for clinical decision support software—in which industry has claimed enhanced regulatory clarity is vital to the continued development and commercialization of health IT products. It also does not address the impact of regulations and claim substantiation guidelines issued by the Federal Trade Commission (FTC), which regulates the advertising of most general health and wellness products, on the risk-based regulatory framework described in the Final Guidance.