Leakage Risk Prompts Class I Recall For Baxter’s Clearlink Chemo Delivery System
The US FDA has labelled a recall of Baxter’s drug delivery system with its most serious classification because leaks could expose patients and providers to hazardous substances.
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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.
As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.