FDA Classifies Brain Temperature Measurement Systems as Class II Devices
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Table of Contents
FDA classified the generic type “brain temperature measurement system” into Class II. This covers externally placed prescription devices, such as the BrainTemp Neonate system, used to monitor brain temperature. The agency determined that Class II classification, combined with specific special controls, provides reasonable assurance of safety and effectiveness for this device type.
Why it matters: This action clarifies the regulatory path for brain temperature monitoring devices and reduces the compliance burden compared to the automatic Class III status. It sets the special controls, including testing and labeling requirements, that manufacturers must follow. While this does not approve a specific product for sale, it creates a standard reference that makes it easier for other companies to bring similar devices to market.
Who it affects
- Manufacturers of brain temperature measurement systems.
The FDA issued this final order in the Federal Register; manufacturers should consult the full text of the order and the codified regulation at 21 CFR 882.1565 for the complete list of special controls before relying on this classification.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document