The US FDA has labelled a recall of Becton Dickinson intraosseous needle set kits, manual driver kits, and powered drivers as class I, its most severe designation.
New Jersey-based medical technology company Becton Dickinson (BD) announced a recall of several of its intraosseous products because of three separate issues that could result in delayed treatment.
The Food and Drug Administration has designated the recall class I, the agency's most serious type.
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Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
