Are you complying with the new FDA General Wellness Policy for Low Risk Devices? General wellness- word is simple but has deeper meaning. There are many devices are available which may fall under medical devices but with low risk like risk level 1. Do they need to be governed by the same strict regulations of FDA? Answer came out through guidance document which FDA published in July 2016 Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices What is in this FDA guidance documents? The reason of a general wellness creation According to this FDA guidance, a general wellness product must 1. Be planned only for general wellness use. 2. Pose low risk to the safety to user and others What does the FDA think to be a General Wellness Product? General wellness products that promotes healthy lifestyle or that promote well known association between healthy lifestyle and certain dieses or condition. That should fall in low risk category but cannot be considered medium or higher risk product even though they may fall in general well ness category. Clear cut definition of general wellness considered, 1. Are intended only of general wellness. 2. Presents low risk of safety to users and other persons. In the claim of such devices there is no mention of dieses or condition. Device may claim physical fitness, mental peace, sleep management. May help to reduce risk of certain chronic dieses but does not mention its name General wellness products may include software programs, (that gets data from primary medical devices without altering them it may change format but not basic data. Like certain mobile application which can be connected to primary medical devices which collects data which can be presented to your doctor. video games to relieve person of certain stress exercise equipment for maintaining physical health and other products that are normally existing from retail establishments or via direct software downloads. The biggest advantage of this general wellness device offered by FDA are exempt from
FDA regulations, such as 21 CFR 807 (Registration, listing and premarket notification), 21 CFR 801 and 809.1 (Labelling), 21 CFR 820 (GMP), and 21 CFR 803 (medical device reporting).