General Wellness: Policy for Low Risk Devices
Draft Guidance for Industry and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only.
Document issued on: January 16, 2015.
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).
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, including those regulated by CDRH.
CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to:
- registration and listing and premarket notification requirements (21 CFR Part 807);
- labeling requirements (21 CFR Part 801 and 21 CFR 809.10);
- good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and
- Medical Device Reporting (MDR) requirements (21 CFR Part 803).