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Drug & Device News
FDA Programs to Improve Safety
The FDA is attempting to increase the safety of medical devices by implementing a new program titled the Postmarket Transformation Initiative. The program, which will allow the FDA to identify, analyze and act on problem medical devices more quickly, is being overseen by the FDA's Center for Devices and Radiological Health's (CDRH). Those involved in this initiative intend to work toward an electronic reporting system for adverse medical device events and improved internal collaboration on post-market safety issues. The team is expected to send its recommendations to the CDRH within 4 months.
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