Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical Electronic Thermometers" and "Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices".
Clinical electronic thermometers are used to measure and monitor the body temperature of patients. These devices are an important screening and diagnostic tool to assist in the identification of individuals who have or may have a range of conditions and illnesses, including those who may be infected with COVID-19.
In this guidance, FDA clarifies its enforcement policies and expectations for clinical electronic thermometers at the end of the COVID-19 public health emergency. This guidance may assist FDA and other stakeholders in transitioning from COVID-19 to normal operations and processes.
This guidance apply to clinical electronic thermometers, which are regulated as Class II devices under 21 CFR 880.2910, product code FLL and these devices include both contact and non-contact clinical electronic thermometers.
This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a Certificate to Foreign Government (CFG) for a device is denied, and the process for seeking review of such a denial.
Click this LINK to know about the Review of FDA Denial of a CFG or CFGNE Request, etc.