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FDA Guidance on Communication Procedures
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical device circulation, announced proposed changes to communication procedures between medical device manufacturers and other...
FDA Issues Guidance on Testing Information
The Food and Drug Administration (FDA), the US medical device regulating agency, issues detailed guidance on format and content of testing information to be provided in the course of premarket application submission. ...
TGA Guidance on IVD Companion Diagnostics
The Therapeutic Goods Administration (TGA), the division of the Australian Department of Health responsible for medical device regulation, issues guidance on IVD companion diagnostic devices. Definition of IVD...
Health Canada Issues Guidance on SaMD
Health Canada, the Canadian medical device regulating agency, has issued new guidance on software as a medical device (SaMD) to provide details on definition and classification.  The Scope of the Guidance   The new...