Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.
[fa icon="clock-o"] 10/5/12 5:08 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Mission, Medical Devices, Substantial Equivalence, Innovation, Intellectual Property, 510(k)
Read More »Eureka! A light bulb goes off, and suddenly you’ve invented a great new medical device that will save millions of lives worldwide every year.
[fa icon="clock-o"] 9/28/12 5:33 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Medical Devices, Patents, Intellectual Property
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