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Fda Guidance Clinical Electronic Thermometers

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For example, in some cases, there is enforcement discretion with respect to FDA review and in other cases there is additionally enforcement discretion with respect to registration and listing, compliance with the Quality System Regulation, and other requirements.

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FDA Principal Deputy Commissioner Amy Abernethy said. Nothing is clinical electronic thermometers can measure surface skin edges of clinical electronic thermometers fda guidance. Some home monitoring technologies are legally classified as medical devices, and others are not. A common symptom of COVID-19 and clinical electronic thermometers.

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Published Literature: Published methods or data referenced in study reports should be made available to FDA upon request.