FDA Working Group Issues 510(k) Medical Device Safety and Effectiveness Recommendations


On August 4, the U.S. Food and Drug Administration’s 510(k) Working Group released its preliminary report which made multiple recommendations for changing the 510(k) pre-market notification process for medical devices. The Working Group was convened by the FDA in September 2009 as part of a two-pronged assessment of the 510(k) clearance process. The Working Group was charged with evaluating the 510(k) program and to recommend actions FDA’s Center for Devices and Radiological Health (CDRH) could take to strengthen the program under its existing statutory authority.

Background and recommendations found in full article.

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