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...
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 medical devices and other healthcare products, has issued a guidance document dedicated to distinguishing medical device recalls from medical device enhancements. The...
Europe
Previously we released an article dedicated to the regulatory framework for medical devices introduced under the Medicines and Medical Devices Act 2021 (the Act), the key element of the UK legislation on medical devices. The present article is dedicated to the...
