Hello Anon,
There are no specific labelling requirements, however you should be careful on any statements or claims being made for wellness devices. There can be a fine-line between health/wellness devices and regulated medical devices. Ensure to read each claim or statement carefully in relation to the applicable regulation.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Oct-2020 08:00
From: Anonymous Member
Subject: Scale device
This message was posted by a user wishing to remain anonymous
Hello
I saw that FDA guidance define weight management is considered as a General Wellness Product.
General Wellness: Policy for Low Risk Devices - Guidance| U.S. Food and Drug Administration | remove preview |
| | General Wellness: Policy for Low Risk Devices - Guidance | | 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). | | View this on U.S. Food and Drug Administration > |
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I would like to understand if there are any labeling requirements for General Wellness Product.
thanks!