FDA
The first article of the cycle provides a brief overview of the Safety and Performance Based Pathway, the ideas behind it, and key underlying concepts. The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices,...
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 guidance describing the most important aspects related to testing and labeling of medical devices for safety...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the self-monitoring blood glucose test systems intended for over-the-counter use. Important Notes The document represents a final version of the document issued previously in November 2018. The...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the medical device regulating authority, has published a final consultation paper dedicated to the Australian Unique Device Identification (UDI) System to be implemented in the country in the course of the ongoing...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific...
