Jan 20 - 5:35
Medical device industry representatives are pushing the Food and Drug Administration (FDA), the US regulating authority, to provide additional clarification regarding the framework that establishes the legal status of...
Dec 30 - 3:03
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...
Dec 27 - 6:47
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. ...
Dec 26 - 5:40
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...
Dec 24 - 4:56
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...
