HSA Draft Guidance on Clinical Evaluation: Definitions
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...
The Food and Drug Administration (FDA or the Agency) issued detailed guidelines dedicated to adverse event reporting rules for medical devices placed on the market under the Emergency Use Authorization (EUA). The EUA is a special regulatory framework implemented by...