Enforcement Policy for Clinical Electronic Thermometers; Guidance for Industry and Food and Drug Administration Staff; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Enforcement Policy for Clinical Electronic Thermometers." This guidance applies to clinical electronic thermometers, which are regulated as class II devices. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Abstract as published in the Federal Register.
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