This message was posted by a user wishing to remain anonymous
I would like to further understand how to use the General Wellness
exemption. If someone has knowledge on how to appropriately use this or more examples that are not listed in the guidance, that would be greatly appreciated. I do have a few questions:
1. Does the manufacturer self-declare that their product is part of the general wellness category?
2. Can manufacturers use the general wellness exemption for a product that could be interpreted to be similar to devices that have a classification regulation? For example, an oximeter, thermometer, breath counters, etc.
3. The guidance says that inclusion under the policy does not establish that is has been shown to be safe and/or effective for its intended use, are there any FDA recommendations for manufacturers to consider when determining how they want to show safety and effectiveness of a general wellness product?
Thank you!