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

Examples of electronic digital contact thermometers

Examples of non-contact infrared thermometers (NCIT)

Mercury thermometers

Examples of 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.

Examples of disposable and color-changing thermometers

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)	21 CFR Part 807 (FDA Establishment Registration and Device Listing); and 21 CFR 807 Subpart E (FDA 510(k) Premarket Notification); and 21 CFR Part 801 (Medical Device Labeling)
Mercury thermometers Disposable and color-changing thermometers	21 CFR Part 807 (FDA Establishment Registration and Device Listing); and 21 CFR Part 801 (Medical Device Labeling)

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 FDA Labeling Requirement (21 CFR Part 801), as well as Amazon’s labeling 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 (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

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 we contact you 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 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, your 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

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.