On July 29, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "General Wellness: Policy for Low Risk Devices," which helps clarify the FDA's Center for Devices and Radiological Health's (CDRH) compliance policy for low-risk products that promote a healthy lifestyle. This is the finalized version of draft guidance released in January 2015 pertaining to regulation of general wellness devices under the Federal Food Drug and Cosmetic Act (FD&C Act). The final guidance provides greater clarity regarding the extent to which a particular mobile medical application or other medical technology product will be subject to the FDA's medical device regulatory oversight and controls under the FD&C Act.
The FD&C Act, a set of laws that gave the FDA authority to oversee the safety of food, drugs and cosmetics, was amended in 1976 to include regulation for medical devices. The amendment required that all medical devices be classified in one of three classes:
- Class I: Devices that do not require premarket approval or clearance but must follow general controls
- Class II: Devices that are cleared using the 510(k) process
- Class III: Devices that are approved by the Premarket Approval process, analogous to a New Drug Application
The final guidance exempts from active FDA oversight devices that are intended only for general wellness use and present a low risk to the safety of users and other persons. This is a welcome step for the fitness/wellness technology industry as it provides greater clarity into the types of devices that will be subject to the FDA's strict scrutiny. The FDA expressly stated in the final guidance that it "does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act and if they are to comply with premarket and postmarket regulatory requirements."
There are two types of general wellness devices which serve two separate purposes. The first type is primarily intended to sustain or offer general improvement to functions associated with a general state of health. The second type has an intended use that relates the role of a 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. This second category of general wellness devices includes two subcategories:
- Intended uses to promote, track, and/or encourage choices which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and
- Intended uses to promote, track, and/or encourage choices which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
Devices whose intended uses are not limited to one of the above intended uses will most likely not be considered low-risk and may be subject to regulation under the FD&C Act. Such regulation is likely if any of the following questions can be answered "yes":
- 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?
In assessing whether a product is low-risk, the FDA recommends that the manufacturer also consider whether the CDRH actively regulates products of the same type as the product in question.
Click here for more Healthcare Blogs from Day Pitney
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.