FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the Breakthrough Devices Program, a special framework intended to facilitate the review of important submissions and accelerate the process of placing vitally important medical...
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), a department of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan, a country’s regulating authority in the sphere of medical devices,...
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....
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