FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, continuously develops and publishes guidance documents dedicated to various medical devices. In these documents, the FDA addresses the most...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices...
FDA
The Food and Drug Administration (FDA or the Agency), the country’s regulating authority in the sphere of healthcare products, has developed detailed guidelines dedicated to labeling requirements for various types of medical devices. The present article supplements...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device license application types. Apart from the general description of existing medical device application types, the...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has developed a guidance document dedicated to the use of electronic source data in clinical investigations related to medicines and medical...
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 issued a guidance document dedicated to distinguishing medical device recalls from medical device enhancements. The...
