Menstrual devices

If you list products on our store, you must comply with all federal, state, and local laws and our policies applicable to those products and product listings, including this policy.

Menstrual devices covered by this policy

A menstrual device is a personal care product used for hygienic purposes during menstruation.

Menstrual tampons

A menstrual tampon is a device that is made of cellulosic or synthetic material. It is inserted into the vagina and used to absorb menstrual flow or other vaginal discharge. Menstrual tampons can be scented or unscented, come with or without applicators, and come in varying degrees of thickness.

Examples of menstrual tampons

Menstrual pads

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.

Examples of menstrual pads

Menstrual cups

A menstrual cup is a receptacle placed in the vagina to collect menstrual flow. Menstrual cups are most often made from silicone and can be single use or reusable. Menstrual discs are included in this category and are often disposable products.

Examples of menstrual cups

Our policy for menstrual devices

Amazon requires that all menstrual devices have been tested to and comply with the specific regulation or standard requirements listed below:

Product	Regulation/Standard requirements
Menstrual tampons	21 CFR Part 807 (FDA Establishment Registration andDevice Listing); and 21 CFR 807 Subpart E (FDA 510(k) Premarket Notification); and 21 CFR Part 801 (Medical Device Labeling)
Menstrual pads	21 CFR Part 807 (FDA Establishment Registration andDevice Listing); and 21 CFR Part 801 (Medical Device Labeling)
Menstrual cups

Required information

We may request this information from you at any time, so we recommend that you have it easily accessible:

• Your company name (if applicable) and seller ID
• Your contact information: email address and phone number
• A list of all menstrual devices that you list
• Product packaging and label images for all menstrual devices that you list
  • Product images must show all sides of the product packaging
  • Product images and detail page content comply with Amazon’s policy for medical devices. For more information on this specific policy and our requirements, visit Amazon’s policy on medical devices and accessories
• Documentation demonstrating all of the following:
  • FDA Establishment Registration number – Screenshot
  • FDA Device Listing – Screenshot
  • FDA 510(k) Premarket Notification (for menstrual tampons only) – FDA Approval Letter
• Test report(s) from an ISO 17025 accredited lab confirming that each product was assessed to 21 CFR Part 801

Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Service Provider Network.

How to submit information

If you are contacted by us for compliance documents, complete the following steps to submit the requested information:

1. In Seller Central, select Performance tab, and choose Account Health.
2. Under Product compliance requests in the bottom right corner of the page, click Documentation requests.
3. Click Provide Documentation or Appeal next to the product.
4. Select No to upload documents.
5. Follow the steps in the Submit required documents section.

Policy violations

If you do not provide the required information by the applicable deadline, we may:

• Remove the relevant product listings
• Suspend your ability to add new products, listing privileges, or both
• Withhold any payments due to you
• Pursue legal action

We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

• Amazon Services Business Solutions Agreement
• Remove inventory overview
• Fix stranded inventory
• FDA’s Device Advice: Comprehensive Regulatory Assistance
• FDA’s Guidance on Premarket Notification for Menstrual Tampons and Pads

Disclaimer

The information provided on this page does not, and is not intended to, constitute legal advice; instead, all information, content, and materials available on this site are for general informational purposes only.