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GUIDANCE DOCUMENT

General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff September 2019

Final
Docket Number:
FDA-2014-N-1039
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).1 This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.2

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions, including those intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, from the definition of device in section 201(h) of the FD&C Act. Section 520(o)(1)(B) of the FD&C Act, states that software that is intended "for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition" is not a device under section 201(h) of the FD&C Act.

This guidance clarifies FDA's interpretation of this provision and its application to general wellness products.

1 This guidance does not change or rescind any requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or any applicable regulations. This guidance also does not preclude FDA from consulting with the Consumer Product Safety Commission (CPSC) as to whether a general wellness product is a consumer product under CPSC's authority or a device. FDA may coordinate with other agencies and authorities, such as the CPSC, to determine jurisdiction over products. If a product is a device under section 201(h) of the FD&C Act, it is generally excluded from CPSC's authority over "consumer products" under the Consumer Product Safety Act (15 U.S.C. § 2052(a)(5)(ii)(H)). However, CPSC and FDA may both have jurisdiction over certain medical devices under other statutory authorities the CPSC administers.

2 For determinations on combination products, contact the Office of Combination Products at combination@fda.gov. See 21 CFR 3.2(e) for the definition of a combination product.  


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-N-1039.