FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published detailed guidelines describing recalls, corrections, and removals in the context of medical devices. The document is intended to...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to Brain-Computer Interface (BCI) devices. The present article address aspects related to the...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to recalls. The document provides general information about recalls and also a detailed description of the main phases of the recall...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document on reprocessing medical devices in healthcare settings. The document highlights the most important aspects...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device recalls. The document provides guidelines to be followed by medical device manufacturers with regard to their products...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device reporting. The document...
