Happy new year to all
I need to find out if we need approval, what kind, and how to get it for a product that will be made from memory foam and placed on the face under an oxygen mask (or the like) for comfort. I assume it would be regulated under Medical devices. I would appreciate any and all help I can get. I have never had to deal with permits and so as a newbe I need a lot of help. If I need a permit, can you spell out what is needed and approx costs involved. Again thanks to all. Seymour:
Thanks Given to Others Edit/Delete Message

Happy new year to all
I need to find out if we need approval, what kind, and how to get it for a product that will be made from memory foam and placed on the face under an oxygen mask (or the like) for comfort. I assume it would be regulated under Medical devices. I would appreciate any and all help I can get. I have never had to deal with permits and so as a newbe I need a lot of help. If I need a permit, can you spell out what is needed and approx costs involved. Again thanks to all. Seymour:
Thanks Given to Others Edit/Delete Message

Hi Seymour,

Happy New Year to you too !:agree:

Btw, I do not know the answer for your question but hope we get responses from other covers. The response may be bit slow due to holiday season.

I have moved your query in the FDA scetion to get more directed responses.

Welcome Seymour,

I read that you could be in a hurry for an answer, thus the duplicate post and if I interpret correctly, I do have your permission to delete the first.

We do have a few 'medical device' Covers on line now and hopefully they will noticed and respond to your query. Meanwhile I think it would be good if you can let us know if this device is to be used externally or is it one of those that need to be 'sterile' and used in ICU's etc.

I read that you could be in a hurry for an answer, thus the duplicate post and if I interpret correctly, I do have your permission to delete the first.

Hi harry, yeah we were on the same boat (thread :)) and I deleted the duplicate thread.

Happy new year to all
I need to find out if we need approval, what kind, and how to get it for a product that will be made from memory foam and placed on the face under an oxygen mask (or the like) for comfort. I assume it would be regulated under Medical devices. I would appreciate any and all help I can get. I have never had to deal with permits and so as a newbe I need a lot of help. If I need a permit, can you spell out what is needed and approx costs involved. Again thanks to all. Seymour:
Thanks Given to Others Edit/Delete MessageI believe that as an accessory or component to the oxygen mask you will have to meet the same requirements as the oxygen mask. Oxygen masks are class 1 but exempt from 510(k) notification but not exempt from the FDA GMP. Start by looking at the FDA Device Advice page (http://www.fda.gov/cdrh/devadvice/) for information.