The Food and Drug Administration (FDA) has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH). This program is just one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process, an expedited approval process granted to moderate-risk medical devices determined to be “sufficiently similar” ... Read More
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