Manage My Compliance UL 4200A - Medical Device
We have a product that is classified as a medical device and we are being told that we are required to have this UL 4200A testing compliance provided to Amazon. Amazon Seller Support does not seem to understand the difference between items. Just because the product has a button battery, doesn't mean it is regulated by CPSC. Below are the references.
MODERATORS, please assist with this.
This product is a medical electronic thermometer which is defined as a Medical Device per 21 CFR SubChapter H.
This product is not defined as a "Consumer Product" per 15 U.S.C. §2052(a)(5)(h) 2022. The definition clearly states that a "Consumer Product" does NOT include "drugs, devices, or cosmetics (as such terms are defined in sections 201(g), (h), and (i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g), (h), and (i)]),).
This product is defined as a "device" and regulated under the Federal Food, Drug, and Cosmetic Act as defined in 21 U.S.C. 321(h)
As this product is a medical device, and not governed by the requirements setforth by the CPSC nor Reese's Law.
5 replies
Glenn_Amazon
Hi there @Seller_L76AwOW2awwbR,
Thank you for reaching out with your concerns with your product requiring these compliance documents. Do you have an open Case with your product I can review.
In general I'm not able to provide specific insights into if your product is or is not compliant, however I can escalate your appeal to the review team.
Thank you for your understanding.
-Glenn
Seller_pjAsuo4DCt4Gu
@Glenn_AmazonHello, I have a similar problem with ASIN B0CWH7VLTG, a cat toy.
I am in the process of getting the product tested, but testing will not be completed by the deadline Amazon has given me to submit the documents.
Can you please tell me how to get an extension of a few more weeks? I am willing and trying to comply, but I need a little more time. Please help. The deadline is May 27.
I just opened a case. Case ID 15322703801 is Thanks.
Glenn_Amazon
Hi there @Seller_pjAsuo4DCt4Gu,
I've reviewed what options exist and I apologize but there is no way to extend the deadline on products requiring compliance documents. If you have FBA inventory you can create a removal order to have the products returned to you and you can send them back in once the testing is complete, the compliance documents accepted, and the ASIN reinstated. I apologize for any difficulties this creates.
Thank you for your understanding.
-Glenn
Seller_pjAsuo4DCt4Gu
@Glenn_Amazon
Thanks for your response. I did receive an answer to my case from support and they suggested this:
"Hello from Amazon Selling Partner Support,
We understand that you are contacting us for extending the deadline to submit compliance documents for reinstatement of ASIN B0CWH7VLTG.
We realize this can be a very important issue to you. And we will handle it with the highest priority.
In this case, we would suggest that you should submit the documents you currently have and request the team to extend your submitted date to another time so it's enough for you to complete your documents before submitting all at once."
So, am I understanding that this option of submitting the documents I currently have and asking for more time to submit the rest of the documents will not work? I just want to verify. Thanks.
Glenn_Amazon
Hi there @Seller_pjAsuo4DCt4Gu,
Based on my understanding and experience the deadlines are generally not adjustable. While it might be possible, it has never been successful in my experience. I would provide as much of your information as possible as it is unlikely to hurt. I would however prepare to create a removal order and then prepare to send the product back in once you have completed the testing. Thank you for your understanding.
-Glenn
