It’s 2 o’clock in the morning and you wake up with a brilliant idea for a new product that will help millions of people. When the cold light of dawn comes, you stop and consider how you’ll navigate the maze of government rules and regulations in order to bring your brainchild to market. Fortunately the U.S. Food and Drug Administration (FDA) just made this a little easier.
The FDA has just issued “General Wellness: Policy for Low Risk Devices,” a document intended to provide “guidance” for the industry and for FDA staff. The “guidance” term is carefully chosen; the report “contains nonbinding recommendations,” so it does not have the weight of a regulation. Still, it is an attempt to help companies understand the agency’s views on the subject. The report defines general wellness products as those that ” (1) are intended for only [their emphasis] general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons.” This is intended to include devices such as exercise equipment, some software apps, and other retail products.
Such products may not make any claims about sustaining or improving health that include reference to any specific disease or condition. You should be okay if you are focused on weight management, stress management, sleep management, or other general health topics. You may run into trouble, however, if you make claims about diagnosing or treating health problems, such as obesity, eating disorders, or autism. It is permissible to refer to illnesses or chronic conditions if your product is intended to help reduce the risk or live with a chronic condition. The key factor is that they are not intended to treat the condition. In order to be considered a low risk device, it must be non-invasive (not penetrating or piercing skin or mucous membranes), not an implant, and not require a procedure that is potentially hazardous (such as lasers or radiation). For example, a sun lamp for tanning or a product that samples blood or other fluids by piercing the skin would not be considered “low risk.”
The report includes a simple three-question checklist that can help you determine whether your product is considered low risk or not. You can read the entire 10-page report here: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf.