FDA Approved Infrared Thermometer

FDA Approved Thermometer: The global infrared thermometer market is going to witness growth in 2020. This pandemic has resulted in a spike in demand for several medical devices, which include a contactless thermometer, monitoring devices for adult infrared thermometers, medical ventilators along with the non contact thermometer.

In an attempt to contain the highly contagious virus, temperature monitoring has become an essential component across public places, including shopping malls, airports, offices, schools, thereby increasing the demand for non contact thermometers.

FDA Approved Infrared Thermometer
FDA Approved Infrared Thermometer

FDA approved medical devices

The products in this section include some of the newest medical technology from the year 2020. The products contain information about what FDA approved medical devices, medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

FDA approved contactless thermometers are easy to use and provide faster results that are highly recommended to measure temperatures in babies and infants. This is increasing the share of the non contact thermometer market. They are considered as reliable, comfortable, and accurate option to measure body temperatures, especially for pediatrics.

Vendors are implementing new technology such as intelligent light indicators to indicate fever levels. They are likely to introduce smart technologies that allow the thermometer to be connected to an external mobile application via Bluetooth.

North America is expected to witness continued improvement, contributing to the highest incremental growth of $75 million by 2025. The evolving consumer confidence and technology is likely to increase the demand for non contact thermometers in clinical medicine.

FDA approved thermometer

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help expand the availability of clinical electronic thermometers, pulse oximeters, etc; to address this public health emergency.

FDA approved thermometer: There is currently an outbreak of respiratory disease caused by a novel virus.

Fever is a common symptom, typically appearing 2-14 days after exposure. Therefore clinical non contact thermometers are an important screening and diagnostic tool to assist in the identification of those individuals who may be infected.

FDA believes the policy set forth in this guidance may help address these urgent public health concerns by helping to expand the availability of clinical non contact thermometers during this public health emergency, thereby helping to prevent or alleviate potential shortages as the demand increases due to usage at critical locations such as airports, hospitals, and other locations where groups of individuals may have been exposed.

FDA Approved Infrared Thermometer
FDA Approved Infrared Thermometer

FDA Approved Infrared Thermometer

In the context of the public health emergency, it is necessary to maintain an adequate supply of the FDA Approved Infrared Thermometer, which is used to measure and monitor the body temperature of patients.

Manufacturers of clinical non contact thermometers are required to submit a premarket notification under section 510(k) of the FD&C Act to FDA and receive FDA clearance prior to marketing these devices in the United States, as well as comply with post-marketing requirements.

However, to help ensure the availability of equipment that might offer some benefit to health care providers and the general public during the public health emergency, FDA does not intend to object to the distribution and use of clinical electronic thermometers that are not currently 510(k) cleared without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: submission of a premarket notification under section 510(k)

Thermometer standard

This section provides recommendations regarding the minimum performance and labeling relevant to the enforcement policy set forth above. FDA encourages firms to discuss any alternatives to these recommendations with the FDA. FDA believes such devices will not create such an undue risk when the following circumstances are present:

The device is manufactured consistently with 21 CFR Part 820, ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes, or equivalent quality system approach; the device has marketing authorization in another regulatory jurisdiction (European CE Mark, Australian Register of Therapeutic Goods Certificate of Inclusion, Health Canada License, or Ninsho certification in Japan), or the performance of the device conforms to the standards, as applicable:

List of FDA approved thermometers

Infrared thermometers that are marketed in the United States have FDA approval, have ISO and ASTM standards.

FDA believes such devices will not create such an undue risk where the performance and labeling elements are met for the FDA approved infrared thermometer. This policy does not apply to previously 510(k) cleared clinical infrared thermometers.

  • Thermometer Standards
    • ASTM E1104-98: Standard Specification for Clinical non contact Thermometer Probe Covers and Sheaths
    • ASTM E1965-98: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
    • ASTM E1112-00: Standard Specification for Electronic non contact Thermometer for Intermittent Determination of Patient Temperature
    • ISO 80601-2-56: Medical electrical equipment: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
    • ASTM E825-98: Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
    • ASTM E1061-01: Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
  • Electrical Standards
    • ANSI/AAMI ES60601-1: Medical electrical equipment: General requirements for basic safety and essential performance
    • ANSI/AAMI/IEC 60601-2: Medical electrical equipment: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
    • ANSI/AAMI/IEC 60601-1-11: Medical Electrical Equipment: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment
FDA Approved Infrared Thermometer
FDA Approved Infrared Thermometer

Amazon FDA thermometer

Amazon ear and forehead thermometer

Braun Thermoscan 7 IRT6520 Thermometer + Bonus 40 ThermoScan Lens Filters

Amazon forehead thermometer

Braun Thermoscan5 ear thermometer. No.1 brand among pediatricians and mom. Proven more accurate than rectal or temple thermometers.

Based on the 2017 Consulting Survey reporting that of the surveyed pediatricians who recommend a brand of thermometers to their patients, Braun is the most recommended brand, and of the surveyed pediatricians that use a branded thermometer, Braun is the most frequently used brand.

The most read

Medical Grade Thermometer

The medical-grade thermometer features a large-screen HD LCD display that clearly gives simple instant readings, one-click measurements, and automatic power-saving shut down after 15 seconds of inactivity.

Infrared Thermometer made in USA

  • What is Top 10 Thermometer Made In the USA in 2020?
  • What is the best medical infrared thermometer made in the USA?
  • What is the best-infrared thermometer made in the USA?

All of these questions above drive you crazy every time they occur to you. We know your doubts because we used to be in this strange situation when looking for a thermometer made in the United States.

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