RegDesk Regulatory Roundup

FDA Guidance on GUDID: Account Roles FDA

FDA Guidance on GUDID: Account Roles

The Food And Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document highlights the most important...

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FDA Guidance on Design Validation FDA

FDA Guidance on Design Validation

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control in the context of medical devices. Among other matters, the document addresses aspects...

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