General Wellness: Policy for Low Risk Devices

OMEDtechDraft Guidance

healthThe FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.”  A general wellness product must either help to maintain a general state of health, or help to reduce the risk or impact of chronic diseases when combined with a healthy lifestyle. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that meet the criteria.

There are two categories of general wellness products.  The first category of general wellness products are for sustaining or improving a person’s general state of health and do not make any reference to diseases or conditions.  These general wellness products may be for: weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function. The second category of general wellness products may help an individual to reduce risk or to live well with certain chronic diseases or conditions when combined with a healthy lifestyle.  Examples of chronic diseases include heart disease, high blood pressure, and type 2 diabetes.

CDRH does not intend to determine whether general wellness products are classified as devices or whether they comply with premarket review and post-market regulatory implementing regulations, including: “registration and listing and premarket notification requirements; labeling requirements; good manufacturing practice requirements as set forth in the Quality System regulation; and Medical Device Reporting requirements.”  CDRH’s general wellness policy does not extend to devices that are not low risk general wellness products. To begin assessing if a device is considered low risk the FDA suggests that you determine if the CDRH currently regulates similar products.


Read the full draft guidance here.