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This article applies to selling in: United States

Medical thermometers

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.

Medical thermometers covered by this policy

Medical thermometers are used to measure body temperature to assess a person’s health and well-being. Medical thermometers can be used to measure temperature via the following routes: oral or sublingual (under the tongue), axillary (armpit), rectal, tympanic (ear), or temporal (forehead). Some thermometers can be worn on the body for continuous monitoring. Medical thermometers can be either electronic or non-electronic devices. Non-electronic devices include mercury thermometers and color-changing disposable thermometers.

Electronic digital thermometers

An electronic digital thermometer is a device that measures a person’s body temperature using a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Electronic digital thermometers include contact and non-contact devices. Non-contact devices include non-contact infrared thermometers (NCIT). An NCIT is a type of electronic digital thermometer that uses infrared technology to measure a person's thermal radiation without the need for any physical contact

Mercury thermometers

A mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

Disposable and color-changing thermometers

A disposable or color-changing thermometer is a disposable device used to measure a person's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by using heat-sensitive chemicals that are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat-sensitive chemicals.

Our policy for medical thermometers

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

Product Regulation/Standard requirements
Electronic digital thermometers (contact and non-contact devices)

All of the following:

  • 21 CFR Part 807 (FDA Establishment Registration and Device Listing); and
  • 21 CFR 807 Subpart E (FDA 510(k) Premarket Notification)

Mercury thermometers

Disposable and color-changing thermometers

All of the following:

  • 21 CFR Part 807 (FDA Establishment Registration and Device Listing);

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 medical thermometers that you list
  • Product packaging and label images for all medical thermometers that you list
    • Product images must show all sides of the product packaging
    • Product images and detail page content must comply with Amazon’s labeling 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 all of 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
  • If your product is intended for children’s use, it is subject to additional requirements. For more information on these specific requirements, go to Amazon’s policy on Children’s Products

How to get compliance services

If you need help getting compliance certifications, testing, and audits use our network of Amazon partners.

How to submit information

If you receive a request from us for compliance documents, complete the following steps to submit the requested information:

  1. In Seller Central, select the Performance tab and choose Account Health.
  2. Under Manage your compliance in the bottom right corner, click Product Compliance Requests.
  3. To add compliance or appeal for a single product, click Add/Appeal Compliance. To add compliance or appeal for multiple products, select each product on the left hand side of the product and click Action Selected Products at the top of the product requirement table to make a selection about how you would like to submit documents and information.
  4. Provide compliance documents and information in the Provide Documents section, or provide appeal information and documents in the Appeal Request section.
  5. Click Submit for Approval to send your submission for review by Amazon.

Note: Test reports must contain images of the tested products that are sufficient to demonstrate that the product tested is the same as the product listed on the detail page.

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, your listing privileges, or both
  • Withhold any payments due to you

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

Additional resources

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

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