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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