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Brazil’s ANVISA has issued new regulations defining registration requirements for medical devices and in vitro diagnostics that likely will require industry to revise technical documents by Oct. 26. Read More
The FDA plans to establish a system that would allow for the use of “real-world evidence” to help the agency more quickly identify safety signals and address concerns, according to its list of strategic priorities for 2016-2017. Read More
The FDA is seeking stakeholder feedback on a proposal to reclassify electroconvulsive therapy devices from Class 3 to Class 2 for treating severe major depressive episodes associated with major depressive or bipolar disorder. Read More
The ISO’s standard for measuring exposure to ionizing radiation has been updated, taking into account the new limit on equivalent dosing to the lens of the eye, as recommended by the International Commission on Radiological Protection. Read More