HELP! How to list a product that is 510(k) exempt Medical Device Classification - New Brand
Running into multiple issues into adding a product on Amazon.
After our Brand Approval and sending photos of our product, I got stuck on the 510(k) number and PMA #.
Our listing draft was not saved and deleted from the Amazon Server. We then had to jump hoops and circle back to the first step. Under Class 1 FDA our tourniquet is exempt.
What is needed to proceed as the product listing for Medical Classification there is nowhere to enter an exemption or what number is needed to be entered to proceed? We have reached out to Amazon and not getting any clear answers as they are offering solutions that are not in direct with our problem. For example, they will send us back to the beginning of submitting photos, or saying to get a ASIN.
The main issue is how to get over the hump of 510(k) and PMA under this classification.
HELP! How to list a product that is 510(k) exempt Medical Device Classification - New Brand
Running into multiple issues into adding a product on Amazon.
After our Brand Approval and sending photos of our product, I got stuck on the 510(k) number and PMA #.
Our listing draft was not saved and deleted from the Amazon Server. We then had to jump hoops and circle back to the first step. Under Class 1 FDA our tourniquet is exempt.
What is needed to proceed as the product listing for Medical Classification there is nowhere to enter an exemption or what number is needed to be entered to proceed? We have reached out to Amazon and not getting any clear answers as they are offering solutions that are not in direct with our problem. For example, they will send us back to the beginning of submitting photos, or saying to get a ASIN.
The main issue is how to get over the hump of 510(k) and PMA under this classification.
1 reply
Danny_Amazon
Hello @Seller_uzJ0QvKg7eIzi- thanks for sharing this experience here on forums. I wanted to make sure you were armed with our help page specific to medical devices, and particularly the following section:
"Registration, Clearance, and Approval
Owners or operators of facilities that are involved in the production and distribution of medical devices intended for use in the U.S. must be registered with the FDA. For more information, go to Device Registration and Listing and Classify Your Medical Device.
Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. Note that most Class I devices are exempt from 510(k) clearance. For more information, go to 510(k) Clearances.
Medical devices must not have been the subject of any unresolved FDA enforcement such as FDA warning letters. For more information, go to Warning Letters."
If you would like to provide me with your case ID where you have provided the exemption to Amazon, I would be interested in taking a look from my end to see how we can best advise!
Thanks much,
Danny
