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FDA Guidance on General Device Labeling FDA

FDA Guidance on General Device Labeling

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...

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FDA Guidance on Recalls FDA

FDA Guidance on Recalls

The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for marketing approval and post-market monitoring and surveillance in the sphere of medical devices, has published an official notice dedicated to special action taken to...

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FDA Guidance on Design Control Basics FDA

FDA Guidance on Design Control Basics

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to design control. The document was issued by the Center for Devices and Radiological Health (CDRH) earlier in...

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