FDA Draft Guidance on Section 524B: Overview
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
The new article further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.
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 software medical devices in the context of a life cycle approach. The document provides...
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 postmarket management of cybersecurity in medical devices. The document is intended to provide...
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 cybersecurity matters related to medical devices. Among other aspects, the guidance addresses the...