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 medical devices and other healthcare products, has published a guidance document dedicated to the interpretation of significant changes to a medical device. In particular, the guidance describes...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the types of medical device license applications. In particular, the document describes how medical devices could be combined when...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The document is intended to provide additional clarifications regarding the applicable regulatory requirements...
FDA
The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the Food and Drug Administration (FDA or the Agency), the US regulating authority, earlier in 1989. Since that time, the document has been...
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