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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
Hospitals and other healthcare institutions must follow certain administrative measures for quality supervision on the use of medical devices, under a new regulation issued by China’s FDA that focuses on procurement, maintenance, supervision and documentation. Read More
The FDA is proposing a new definition for “convenience kits,” narrowing the meaning of the term for two or more different medical devices packaged together. Read More
The FDA is looking to stakeholders for input on how to overcome barriers to access and spur the development of hearing aids — devices that often are underutilized by hearing-impaired people. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
Sunlamp manufacturers would be required to take additional measures to improve the overall safety of tanning beds under new rules proposed by the FDA. Read More