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GUIDANCE DOCUMENT

Enforcement Policy for Clinical Electronic Thermometers Guidance for Industry and Food and Drug Administration Staff November 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-N-4372
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for clinical electronic thermometers at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.

In conjunction with the issuance of this guidance, FDA is proposing to exempt clinical electronic thermometers without telethermography or continuous temperature measurement functions from premarket notification requirements under section 510(m) of the Federal Food, Drug and Cosmetic Act. FDA intends to withdraw this guidance after any final exemption notice has been published in the Federal Register.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-N-4372.

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