FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to reprocessing medical devices in healthcare settings. In particular, the document provides additional...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published an official information notice dedicated to custom-made medical devices. The notice is intended to provide...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the early collaboration meetings in the context of the FDA Modernization Act (FDAMA). The latest version...
Asia
The Health Sciences Authority (HSA), Singapore`s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the medical device unique device identification (UDI) system. The latest version of the...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a Questions-and-Answers document dedicated to the Electronic Medical Device Reporting (eMDR). The document is intended to provide...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a safety communication dedicated to the reprocessing of flexible bronchoscopes. The document provides...
