Class I Recall For Integra’s CereLink Intracranial Pressure Monitors
The US FDA has labelled a June recall of intracranial pressure monitors from Integra with its most serious designation, class I.
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Integra LifeSciences has recalled CereLink intracranial pressure monitors because of reports they were providing inaccurate readings. The company adjusted its third quarter earnings expectations in response.
FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.
As part of a policy revamp, FDA encourages COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.