CDRH’s Courtney Evans explained the four unique considerations that connected combination manufacturers products should assess when working with the US FDA.
Connected combination products require special regulatory considerations, a team lead at the US Food and Drug Administration’s device center said during a recent industry conference.
Courtney Evans, an injective devices team lead at the Center for Devices and Radiological Health, spoke on 9 November at...
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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.
