Menstrual panties or period panties have to provide FDA approval letter?
I am a foreign seller and sell menstrual pants.
When Amazon requests the FDA Establishment Registration number (21 CFR Part 807) and
FDA Device Listing (21 CFR 807), I asked my country's attorney if they can do it, but they said that menstrual underwear products do not need to have this certification.
-> So, I want to ask US domestic sellers, are you required to submit this certificate when you start selling on Amazon?
Really need help from everyone. Thank you
Menstrual panties or period panties have to provide FDA approval letter?
I am a foreign seller and sell menstrual pants.
When Amazon requests the FDA Establishment Registration number (21 CFR Part 807) and
FDA Device Listing (21 CFR 807), I asked my country's attorney if they can do it, but they said that menstrual underwear products do not need to have this certification.
-> So, I want to ask US domestic sellers, are you required to submit this certificate when you start selling on Amazon?
Really need help from everyone. Thank you
0 replies
Stevie_Amazon
Hi there @Seller_MKidBf0i5MrJ9,
I am a foreign seller and sell menstrual pants.
When Amazon requests the FDA Establishment Registration number (21 CFR Part 807) and
FDA Device Listing (21 CFR 807), I asked my country's attorney if they can do it, but they said that menstrual underwear products do not need to have this certification.
Thank you for providing this information.
Per this particular policy, sellers must comply with all local, state, federal laws in addition to Amazon policies. Even if your product is not directly a menstrual device, there must be something within the listing that indicates or alludes to the item being considered a menstrual device.
"A menstrual pad is a device made of cellulosic or synthetic material used to absorb menstrual flow or other vaginal discharge. Menstrual pads can be scented or unscented, reusable, and come in varying degrees of thickness and length. Menstrual panties are included in this category and are often reusable products."
Does the description of your item refer to any process that has to do with menstruation?
As it is being flagged as such an item, you will have to provide the requested information, such as the 21 CFR Part 807 (FDA Establishment Registration and Device Listing)
- Your company name (if applicable) and seller ID
- Your contact information: email address and phone number
- A list of all menstrual devices that you offer on our store
- Product packaging and label images for all menstrual devices that you offer on our store
- Product images must show all sides of the product packaging
- Product images and detail page content must comply with Amazon’s policy for medical devices. For more information on this specific policy and our requirements, go to Amazon’s policy on medical devices and accessories
- Documentation demonstrating the following:
- FDA Establishment Registration number (21 CFR Part 807) – screenshot
- FDA Device Listing (21 CFR 807) – screenshot
- FDA 510(k) Premarket Notification (21 CFR 807 Subpart E) – FDA Approval Letter
All the best,
Stevie
