By 3L Kaitlyn Crobar
The development of any health, medical, or medicinal product involves a decision about whether the FDA has a role in regulating it. However, there are certain products that the FDA recognizes as “wellness products”—these are exempt from FDA regulation. For innovators in the health field, determining whether to proceed to market by defining an innovation as a “wellness product” requires careful consideration. The following article reviews considerations for determining whether an invention is a medical device, or a general wellness product.
What is the difference between a medical device and a general wellness product?
A medical device is defined by section 201(h) of the Federal Food Drug & Cosmetic Act, as any “instrument, apparatus, implement, machine … or other similar or related article, including any component, part, or accessory … intended for use in the diagnosis of disease or other [health] conditions.” If a product meets the definition of a medical device, it is subject to some level of FDA regulation based upon the specific classification and required process for that class.
The overriding purpose of regulation is to assure that regulated products are safe for use and effective for the intended use. As outlined in FDA guidance document—“General Wellness: Policy for Low Risk Devices”—general wellness products are those that pose a low risk to the safety of users and other persons in terms of function and are intended only for “general wellness use.” General wellness products are not subject to FDA regulation.
How can status as a general wellness product be determined?
General wellness products have “(1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”
Appropriate intended uses for the first category of general wellness products, which make no reference to any disease or conditions, might include maintaining weight, facilitating sleep, relaxation, stress management, physical fitness, or mental acuity exercises. Products may include exercise equipment, audio recordings, and video games. These products are distinct from those that claim to treat a disease or disorder and that are invasive, implanted, or involve technology that poses a risk to other persons if specific regulatory controls are not applied (such as risk of radiation exposure). These products are not “low risk” and do not qualify as a general wellness product.
The second category of general wellness products refers to diseases of conditions, and includes intended uses of promoting, tracking, managing, and encouraging choices that may help reduce the risk of or may help living well with a chronic disease or condition.
These products include certain software functions “intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease of condition.” An example of this type of general wellness product is software that monitors and records food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity.”
The FDA maintains the webpage How to Determine if Your Product is a Medical Device to help determine the appropriate level of review for devices. This information includes how to contact the FDA if after going through the four methods suggested, the guidance is still not clear.
Why would a developer want to classify an invention as a general wellness product instead of a medical device?
General wellness products are FDA exempt, and therefore an invention can go to market without the 510(k) clearance necessary for Class II devices or pre-market approval required for Class III devices.
General wellness products do not have to comply with annual registration and fees required of all medical device manufacturers. They do not have to register the product in the Registration and Listing Database. These advantages may sound enticing, but before marketing an invention as a general wellness product, the following should be considered:
- FDA approval or clearance may add value to an invention.
Marketing an invention as FDA approved, cleared, or even registered signals to consumers that it meets a minimum standard of safety and efficacy. FDA compliance is also relevant in designating the product as reimbursable by insurance.
- If an invention is marketed erroneously as a general wellness device and the FDA believes the intended use does in fact make it a medical device—as defined by Section 201(h) of the FD&C Act (21 USC 321(h))—a company can be penalized, or even be shut down.
For example, the ancestry site 23andMe offers a product that utilizes genotyping to detect select clinically relevant variants in the genomic DNA of adults from saliva for the purpose of reporting and interpreting genetic health risks and reporting carrier status, such as a person’s chances of getting certain cancers or Alzheimer’s. This product was not intended to diagnose any disease. It was initially brought to market without FDA approval. In 2015, the FDA notified 23andMe of concerns about the genetic interpretations it was providing consumers, as several of these health factors can arise from environmental and lifestyle factors as opposed to mere genetics. The 23andMe assessments were therefore deemed misleading and 23andMe had to obtain FDA approval for its health data and “carrier status” reports.
- FDA Regulatory compliance has an impact when defending tort claims.
Choosing the fastest path-to-market may be shortsighted given the difference FDA approval or clearance can make when defending a lawsuit. A device that is marketed after successfully navigating the FDA Premarket Approval (“PMA”) process has a better ability to defend against tort claims alleging products liability, negligence, or breach of warranty allegations. The 510(k) clearance process for Class II devices also offers a better ability to defend than if a product had not obtained clearance. Even though most Class I devices are exempt from 510(k) clearance, registration and compliance with other requirements—such as good manufacturing practice requirements set forth in the Quality System regulations—may assist in defending against tort claims.
Further Reading
- Federal Food, Drug, and Cosmetic Act201(h) (11 U.S.C. §321(h)).
- Rebecca S. Eisenberg, “The Role of FDA in Innovation Policy,” University of Texas School of Law
- “FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion,” S. Food and Drug Administration
- Julia Belluz, “The FDA ordered 23andMe to stop offering users unapproved health tests. Now it’s back,” Vox (Oct. 15, 2015)
- “General Wellness: Policy for Low Risk Devices,” US Food and Drug Administration