The FDA has determined that low-risk general wellness devices that promote a healthy lifestyle will be exempt from regulation.
CDRH defines wellness devices as products that are intended for only general wellness use, as defined in final guidance released July 28.
The final guidance remains little changed from draft guidance released on Jan. 20, 2015. The biggest change is in section six of the guidance, which presents a decision algorithm for determining whether general wellness products are within the scope of the guidance.
The guidance clarifies that general wellness products fall into two categories: those that are intended to encourage a state of health or healthy activity, or to help reduce or impact certain chronic diseases “where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” the guidance says.
Examples of general wellness devices include those that make claims related to weight management, physical fitness, relaxation or stress management and sleep management.
However, devices that make claims to treat or diagnose obesity or to treat an eating disorder would not fall under the scope of the guidance.
Examples of devices that fall under the second category include software that teaches breathing or relaxation techniques that might help reduce migraine headaches, or software that tracks and records sleep, work and exercise to help people living with anxiety.
Examples of products that are not low risk would include sunlamp products, implants for improving body image, or a laser product that claims to improve confidence by rejuvenating the skin.
Read the guidance here: www.fdanews.com/07-29-16-lowriskdevices.pdf. — Tamra Sami