FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the mouse embryo assay (MEA) for assisted reproduction technology (ART) devices. Due to its legal nature, the document does not introduce mandatory rules and requirements the parties...
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published detailed guidelines describing the most important aspects related to the Essential Principles. The publication is intended to provide medical device manufacturers, sponsors, and other parties...
FDA
The Food and Drug Administration (FDA) of the US has published an updated version of its guidance document dedicated to the coagulation systems for measurement of viscoelastic properties. The initial version of the guidance was published earlier on January 14, 2021....
MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the off-label use of medical devices. The scope of the guidance covers only the medical devices...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices has published detailed guidelines dedicated to sponsorship with regard to placing medical devices on the Australian market. Regulatory Background According...
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