FDA Issues Preliminary Reports on the 510(k) Program and Use of Science in Decision Making for Medical Devices

On August 4, 2010, the U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health (“CDRH” or the “Center”) released a twovolume set of documents entitled, “Center for Devices and Radiological Health Preliminary Internal Evaluations,” which reflect the work of two different internal agency committees to improve the pre-market notification process, commonly referred as the “510(k) process.” This is the primary vehicle by which medical devices are granted marketing authorization in the United States. The document encompasses two preliminary reports with proposals to reform the 510(k) program, one by the 510(k) Working Group and the other by the Task Force on the Utilization of Science in Regulatory Decision Making (“Task Force”). The reports were issued in response to concerns raised both within the agency and in the general community about weaknesses in the current 510(k) program and cover several recommendations that address FDA’s public health objectives for medical devices.

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