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The agency said that sensitivity below 80 percent will not be considered acceptable for authorization because the tests could produce too many false negative results. Read More
Sponsors that import or supply devices in Australia would need to verify that device manufacturers have assigned a UDI to their device and have placed it on the device, on labeling and on packaging. Read More
Effective Oct. 1, Australia’s Therapeutic Goods Administration is requiring devicemakers of Class I non-measuring, non-sterile devices to provide a declaration of conformity with their applications to list on the Australian Register of Therapeutic Goods (ARTG). Read More
In two new guidances, the FDA calls for different types of information in 510(k) premarket submissions for blood glucose monitoring systems for use by healthcare professionals as compared to those for home use by lay-users. Read More
FDA hit Columbus, Ohio-based Battelle Memorial Institute with a warning letter for failure to comply with terms of its Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators. This marks the first warning letter FDA has sent out regarding a product with a COVID-19-related EUA. Read More
Australia’s Therapeutics Goods Agency (TGA) has issued a new consultation paper on its plan to establish a unique device identification (UDI) system and it wants to hear from device sponsors. Read More