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 Brain-Computer Interface (BCI) medical devices. The document highlights the most important aspects...
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 IVD analyzers. Among other issues, the document provides additional clarifications...
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 describing in detail the acceptance review for the requests submitted under the De Novo classification process....
Asia The Directorate General of Pharmaceutical Affairs and Drug Control, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements related to the registration of high-risk medical...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published several guidance documents dedicated to the De Novo Classification Process. One of the documents provides a brief overview of the...
Canada Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the investigation of safety- and performance-related issues associated with medical devices. Apart from other aspects, the document...
