USA: FDA issues guidance to expand availability of clinical electronic thermometers during COVID-19 pandemic
The United States Food and Drug Administration (FDA) has issued temporary guidance to expand the availability of clinical thermometers during the COVID-19 outbreak. In the guidance, the FDA states that it will not object to the distribution and use of clinical electric thermometers without a premarket notification, 510(k), given that the devices do not create risk.
Clinical electronic thermometers must abide by minimum performance and labeling standards under FDA policy. Some of the labeling requirements include:
- Manufactured device must be consistent with 21 CFR Part 820
- Device has marketing authorization in another regulatory jurisdiction
- Device labeling includes a clear description
- Label should include: device performance, potential risks, cleaning and reprocessing instructions etc.
The policy will remain in effect for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS).
Click here to view the guidance.
How TSG can help
TSG’s consultants have experience working directly with the FDA. We can determine if your device is compliant with this temporary guidance or if you need to submit a 510(k). Our consultants also have experience submitting 510(k)’s.
Complete the form if you have any questions about this new guidance, or need help reviewing labels and performance claims.