On April 4, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance on “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance relaxes certain regulatory requirements normally mandated for marketing clinical electronic thermometers to alleviate potential shortages of such devices during the COVID-19 health crisis. FDA’s policy is effective only for the duration of the COVID-19 public health emergency.
Because fever is a common symptom associated with COVID-19, electronic thermometers, which are regulated as Class II devices under 21 CFR 880.2910, are important screening and diagnostic tools. During the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of contact and non-contact clinical electronic thermometers that are not 510(k) cleared, if the use of such devices will not create an undue risk. FDA also will not require compliance with other device regulations, including those that pertain to Reports of Correction and Removals, Registration and Listing, and Unique Device Identification. FDA lists the following recommended minimum performance and labeling elements under which it believes such electronic thermometers will not create an undue risk:
- The device is manufactured using a quality management system or quality system approach consistent with 21 CFR Part 820.
- The device has marketing authorization in another regulatory jurisdiction (e.g., European CE Mark, Australian Register of Therapeutic Goods Certificate of Inclusion) or the device’s performance conforms to a provided list of standards, as applicable.
- The device labeling includes a clear description of available data relating to the device indications or functions including:
- Method of determining temperature.
- Potential risks. Cleaning/reprocessing instructions.
- The device labeling includes a clear identification that the device is not FDA approved or cleared.
FDA encourages firms to send alternatives to these recommendations to CDRH-COVID19-Thermometers@fda.hhs.gov.
FDA also provides links to the current edition of the FDA-recognized standards referenced in the document and links to online resources that may be helpful in evaluating the performance of the device.
1 21 CFR 806
2 21 CFR Part 807
3 21 CFR Part 830 and 21 CFR 801.20.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.