federal_register: 2023-24291

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2023-24291 Enforcement Policy for Clinical Electronic Thermometers; Guidance for Industry and Food and Drug Administration Staff; Availability Notice 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. 2023-11-03 2023 11 https://www.federalregister.gov/documents/2023/11/03/2023-24291/enforcement-policy-for-clinical-electronic-thermometers-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2023-11-03/pdf/2023-24291.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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