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
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
