Low Risk Device Guidance Out

FDA has issued a guidance, General Wellness: Policy for Low Risk Devices, to clarify the CDRH compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). In it, the agency says CDRH does not intend to examine these products to determine whether they are devices within the meaning of the Federal Food, Drug, and Cosmetic Act. And if they are devices, it does not intend to determine whether they comply with the pre-market review and post-market regulatory requirements for devices under the act and implementing regulations.

For purposes of the guidance, general wellness products are defined as products that (1) are intended for only general wellness use and (2) present a low risk to the safety of users and other persons. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, although not exclusively, available from retail establishments.