On July 29, 2016, the Food and Drug Administration's (FDA or the Agency) Center for Devices and Radiological Health (CDRH) finalized a guidance framing enforcement discretion policy regarding Low Risk General Wellness Devices that are intended to promote a healthy lifestyle (Guidance). The Agency released its draft policy in January 2015, which we previously summarized.
The final Guidance largely adopts CDRH's approach from its January 2015 draft. Specifically, CDRH does not intend to examine low risk general wellness products to determine whether they are medical devices within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA), and if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FDCA and implementing regulations (e.g., 21 CFR Part 807 (premarket notification); 21 CFR Part 801 and 21 CFR § 809.10 (labeling); 21 CFR Part 820 (good manufacturing practices/Quality Systems); and 21 CFR Part 803 (Medical Device Reporting (MDR) requirements)). In other words, CDRH does not intend to actively regulate products that meet the definitions in the Guidance, regardless of whether the product would otherwise meet the definition of a medical device under section 201(h) of the FDCA. The Guidance does not apply to any products regulated by FDA's other Centers (e.g., drugs, biologics), or to combination products.
CDRH did, however, make several clarifications in the final Guidance and provided additional examples that may be useful for industry in assessing the regulatory status of devices, as described in greater detail below. CDRH also announced that it will be holding a webinar on September 1, 2016 from 12:00 p.m. - 1:30 p.m. EST to discuss the final Guidance.
CDRH did not substantively change the definition of "general wellness products," which the agency defines as "products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a very low risk to the safety of users and other persons" (changes in bold). The final Guidance reiterated that general wellness products "may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), when consistent with the two factors above.
FDA maintained that a product's inclusion under the general wellness policy "does not establish that it has been shown to be safe and/or effective for its intended use."
Intended for General Wellness
The final Guidance did not substantively change CDRH's classification of a general wellness product. Specifically, CDRH finalized that a general wellness product, has (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 associates 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). If a product's intended uses are not limited to the above general wellness intended uses, the policy articulated in the guidance does not apply.
CDRH did not substantively change what it considers to be general wellness intended uses in the first category and finalized the examples of general wellness claims included in the January 2015 draft. CDRH did clarify the third example by adding "… the flow of qi 'energy'" and added a new example: "Claims to enhance learning capacity."
For the second category of general wellness intended uses, CDRH clarified that this category "relates to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions" (emphasis in original). However, CDRH finalized the two subcategories as proposed in the draft.
CDRH did clarify that disease-related general wellness claims for both subcategories about healthy lifestyle choices may come from peer-reviewed scientific publications, as well as "official statements made by healthcare professional organizations," which CDRH said include "associations and colleges such as the American Medical Association (AMA), American heart association (AHA), American Association of Clinical Endocrinologists (AACE), American College of Rheumatology, etc." In addition, the final Guidance added three new examples of this category of disease-related general wellness claims.
- 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.
Determining Risk for General Wellness Products
CDRH slightly revised its prior risk classification approach in the draft policy and explained that the final Guidance "applies only to general wellness products that are low risk." FDA described in a footnote that a Class I device is "not necessarily … [a] 'low risk' [device] for purposes of the" Guidance. Accordingly, CDRH significantly revised its decision tree and noted that if the answer to any of the following questions is YES, the product is not low risk and is outside the scope of the Guidance.
- Is the product invasive?
- Is the product implanted?
- Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
Accordingly CDRH reemphasized that when assessing whether a product is low risk for purposes of the Guidance, FDA recommends that industry and stakeholders "consider whether CDRH actively regulates products of the same type as the product in question." Further, CDRH outlined two new examples of products that would not be considered "low risk":
- a neurostimulation product that claims to improve memory, due to 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. Such a product is not low risk because it is invasive (e.g., obtains blood samples by piercing the skin) and also because the product 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).
The final Guidance also kept the draft examples of products that CDRH considers to be "low risk" and added the following new example:
- Illustrative Example 4: A mobile application that reminds users to keep exposed skin out of direct sunlight when the UV index is high, which, as part of a healthy lifestyle, may help reduce the risk of skin cancer.
This claim relates to tracking preventive measures which, as part of a healthy lifestyle, may help reduce the risk of a medical condition. The claim is for a healthy lifestyle choice and it is generally accepted that the choice may play an important role in health outcomes. Thus, it is a general wellness claim. In addition, the technology reminding users to keep exposed skin out of direct sunlight does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied. Therefore, this product meets both factors for a low risk general wellness product.
CDRH also clarified its example about the product intended to mechanically exfoliate skin, explaining that the product "cannot be used in a manner that penetrates or pierces the skin."
Although the guidance provides a good starting point for assessing whether a proposed product could fall within FDA's enforcement discretion policy, as manufacturers continue to develop innovative tools with novel features and functionalities, questions are certain to arise about the limits of agency's enforcement discretion policy with respect to general wellness devices. For companies developing new products or adding new features to existing general wellness tools (such as mobile wellness or lifestyle "apps"), a comprehensive analysis of the regulatory status and basis for marketing and, where the regulatory status is ambiguous, obtaining input from FDA prior to launching the product, is advisable. Absent careful analysis, such companies could find themselves inadvertently facing the same level of onerous regulation as more traditional medical device manufacturers.
Manufacturers and product developers will also need to continue scrutinizing advertising and promotional materials to ensure they carefully articulate intended uses and avoid disease or condition-specific claims that could bring scrutiny or enforcement from CDRH. Thus, companies should continue to consider monitoring relevant websites or promotional claims created by third party vendors or downstream retailers that could be attributed to the company. Employees and vendors should also be trained to understand the types of claims and statements they can make on behalf of the company (e.g., through websites, social media presence, press releases, etc.).