Feb 26, 2020
North America
The Center for Devices and Radiological Health (CDRH), the FDA division focused on ensuring the safety of medical devices available on the market, published new online learning tools intended to assist medical device manufacturers in familiarizing themselves with...
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Dec 2, 2019
North America
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on manufacturing and performance of medical devices,...
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Sep 16, 2019
North America
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released four final guidances in an effort to improve the efficiency of its 510(k) marketing authorization pathway. Special 510(k) Program Abbreviated 510(k) Program Format...
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