Regulatory Open Forum

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  • 1.  General Wellness

    This message was posted by a user wishing to remain anonymous
    Posted 04-Feb-2019 09:33
    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?


  • 2.  RE: General Wellness

    Posted 09-Feb-2019 14:43
    If you're intending to market the product in the US, look at the ​guidance document titled "General Wellness: Policy for Low-Risk Devices". It gives some examples to help decide if you fit that category.

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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  • 3.  RE: General Wellness

    Posted 21-Mar-2019 06:47
    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
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  • 4.  RE: General Wellness

    Posted 21-Mar-2019 15:54

    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
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  • 5.  RE: General Wellness

    Posted 22-Mar-2019 04:47
    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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  • 6.  RE: General Wellness

    Posted 22-Mar-2019 10:53

    Hi Mike,

    Yes, this was one question we raised with FDA during a Q-sub (pre-submission) meeting.  If you have a specific product in question I recommend using the Q-sub program.  The feedback provided by FDA was very useful!

    Best,
    Brittany



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    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
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  • 7.  RE: General Wellness

    Posted 22-Mar-2019 11:03
    Thanks once again for your help, Brittany   
    Hope you have a great weekend.

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    Mike Kilkelly
    Quality Manager
    Galway
    Ireland
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