The FDA released a draft guidance for low risk devices on January 20th. The guidance addresses low risk, or general wellness, products that support a healthy lifestyle. Such products include exercise equipment, audio recordings, video games, software programs, apps and wearable devices like the Fitbit. Their uses may include promoting fitness, sleep, relaxation and a healthy weight.
Products not included under the general wellness category are those that claim to treat or diagnose a medical condition. The guidance is not applicable to drugs, biologics, dietary supplements, food, cosmetics, and medical devices that must be FDA approved. Comments or suggestions regarding the draft guidance can be made within 90 days.
Read the FDA draft guidance here
