On January 16, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding FDA’s Center for Devices and Radiological Health’s (CDRH) compliance policy for general wellness products. According to the guidance, CDRH does not plan to regulate general wellness products for compliance with medical device regulations, including registration, listing, premarket notification, labeling, and good manufacturing practice requirements. The guidance applies only to products regulated solely by CDRH, not to products regulated by any other FDA office or any combination products.
What does CDRH consider to be a general wellness product?
CDRH defines “general wellness products” as products that are intended exclusively for general wellness use and present a very low risk to users’ safety. Some examples given for general wellness products include exercise equipment, video games, and audio recordings.
What is a general wellness use?
According to the guidance, a general wellness use is:
“an intended use that relates to maintaining or encouraging a general state of health or healthy activity”
“an intended use claim that associates 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.”
How does CDRH determine whether a product is low risk?
CDRH does not consider a product to be a low risk general wellness product if:
- The product is invasive
- The product involves an intervention or technology that may pose a risk to a user’s safety if the device controls are not applied, such as risk from lasers, radiation exposure, or implants
- The product raises novel questions of usability
- The product raises questions of biocompatibility
For products that do not meet any of the above criteria, CDRH suggests that the owner of the product consider whether CDRH actively regulates products of the same type. For example, if CDRH regulates a similar product as a class II device, it’s probable that the product will not be considered low risk.
What types of claims can be made about a general wellness product?
General wellness product claims can claim to promote or improve conditions or functions associated with a general state of health, such as weight management, self-esteem, stress management, and sleep management. For example, “This product boosts self-esteem” or “this product helps to manage sleep by tracking sleep trends.”
General wellness product claims cannot claim to directly treat or diagnose a disease or condition, such as “this product treats obesity” or “this product diagnoses autism.” General wellness product claims can, however, claim to promote, track, or encourage healthy lifestyle choices that are widely recognized as choices that reduce the risk of or help living well with certain diseases and conditions. For example, “this product promotes physical activity, which is known to reduce the risk of high blood pressure.”
Registrar Corp is an FDA compliance firm that assists medical device companies with FDA regulations. Registrar Corp can help companies determine whether or not their product is considered a low risk general wellness product and review product claims for FDA compliance. For assistance with the general wellness product guidance or other FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or through the 24-hour Live Help chat service: https://www.registrarcorp.com/livehelp.