FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for marketing approval and post-market monitoring and surveillance in the sphere of medical devices, has published an official notice dedicated to special action taken to...
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 postmarket management of cybersecurity in medical devices. The final version of the document was issued...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a user guide on the post-market review compliance dashboard. The document describes in detail how responsible parties can access, review and...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to design control. The document was issued by the Center for Devices and Radiological Health (CDRH) earlier in...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the types of medical device license applications. In particular, the document describes how medical devices could be combined when...
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 discussion paper dedicated to strengthening cybersecurity practices associated with servicing medical...
