Oral health care consumer product for Children

cosmeticqg

Involved In Discussions
Hello All,
My sales and marketing team wants to market an existing oral health care consumer product, class 1 medical device in the US, as a children's product. We have been manufacturing this product for over 15+ years and have substantial post-market data to demonstrate that there are no risks associated with the normal use of this product. I want to extrapolate this data and generate a rationale that will help us support safety and efficacy for children. Of course, this cannot be my only data point-- does anyone know what other tests and evaluations I can leverage?
Here's what I had in mind:
1. Review of post-market data
2. Usability study to demonstrate that the product is suitable for children
3. Benchtop test/study-- what would be recommended here?
4. Medical expert opinion
Because this is a class 1, I am assuming the children product requirements under CPSC also apply.
Thanks everyone for your thoughts and insights!
 

cosmeticqg

Involved In Discussions
Hello All,
My sales and marketing team wants to market an existing oral health care consumer product, class 1 medical device in the US, as a children's product. We have been manufacturing this product for over 15+ years and have substantial post-market data to demonstrate that there are no risks associated with the normal use of this product. I want to extrapolate this data and generate a rationale that will help us support safety and efficacy for children. Of course, this cannot be my only data point-- does anyone know what other tests and evaluations I can leverage?
Here's what I had in mind:
1. Review of post-market data
2. Usability study to demonstrate that the product is suitable for children
3. Benchtop test/study-- what would be recommended here?
4. Medical expert opinion
Because this is a class 1, I am assuming the children product requirements under CPSC also apply.
Thanks everyone for your thoughts and insights!
Hi All- I'm curious if I should move this post to another thread? Thoughts?
 
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