FDA Guidance: General Wellness: Policy for Low Risk Devices, 7/16

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In July, 2016, the CDRH branch of the FDA published Guidance for Industry and FDA Staff – General Wellness: Policy for Low-Risk Devices. This guidance document is intended to provide clarity to the industry and FDA staff on the compliance policy for low risk products that promote a healthy lifestyle (general wellness products).

A general wellness product, for the purposes of this guidance, must (1) be intended only for general wellness use, and (2) must pose 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, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded).

The guidance contains many examples of products that do and do not fall within the general wellness category. The document also contains a decision algorithm for identifying general wellness products.

For more discussion regarding FDA’s regulatory approach towards certain mobile medical applications, see the FDA Guidance: Mobile Medical Applications, issued in 2015.