Many thanks for that Brittany.
Did you actually contact the FDA about this? I'm wondering how one can confirm that their product is or is not a wellness product after they have made their own assessment.
I know there is an email address to ask questions on general wellness products but Im wondering if the FDA will issue a letter or opinion confirming that they consider the product as a general wellness product.
regards
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
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Original Message:
Sent: 21-Mar-2019 15:53
From: Brittany Gibson
Subject: General Wellness
Hi Mike,
In short, the answer is no. If a product classification exists for the product type, the FDA Guidance on General Wellness devices states that any product regulated by CDRH won't be considered as a general wellness device. Even if the indications for use/intended use are different, if the product type is regulated there are safety and effectiveness requirements, and sometimes special controls that apply to the product.
I hope this helps!
Brittany
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Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
Original Message:
Sent: 21-Mar-2019 06:46
From: Mike Kilkelly
Subject: General Wellness
Hi Did you get an answer to your question "Can a manufacturer claim their product is for general wellness even if there is a product classification the product could fit with?"
I have the same question
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Mike Kilkelly
Quality Manager
Galway
Ireland
Original Message:
Sent: 03-Feb-2019 22:58
From: Anonymous Member
Subject: General Wellness
This message was posted by a user wishing to remain anonymous
Please tell me more about General Wellness. Is this something a manufacturer 'self-declares'? Can a manufacturer claim their product is for general wellness even if there is a product classification the product could fit with?
Are there advantages or disadvantages to using general wellness?