FDA’s Latest Update on Class II Clinical Electronic Thermometers
This blog was originally posted on 7th November 2023. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.
FDA’s Proposal for Streamlining Pre-Market Requirements
On 3rd November 2023, the Food and Drug Administration (FDA) published a Notice with request for comments regarding certain class II clinical electronic thermometers that may be exempt from pre-market notification requirements, subject to certain limitations.
New Product Codes for Enhanced Device Classification
The FDA has identified certain class II devices that, if finalized, would no longer require pre-market notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in § 880.9, inlcuding a Clinical electronic thermometer.
The FDA will assign new product codes to clinical electronic thermometers with telethermography functions and those with continuous temperature measurement functions in order to ensure that these devices can be identified distinctly from devices that will be exempt subject to the partial limitations under the existing product code.
The FDA is requesting public comments by 2nd January 2024. The FDA will review any comments submitted and will consider any potential modifications to the exemption for certain clinical electronic thermometers prior to publication of its final determination in the Federal Register .
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