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FDA Plans To Modernize 510(k) Program - Covering the specialized field of orthopedic product development and manufacturing

Importantly, we’ve increased expectations for the quality and quantity of information required in 510(k) submissions, resulting in a more than doubling of the size of submissions—now, an average of 1,185 pages, compared to 475 pages in 2009. And while our reviewers have spent more time reviewing applications during this same period—an increase of about 32 percent—the average total time for the agency to reach a decision has decreased, reflecting a more robust and efficient program. These metrics reflect not only the strengthening of the medical device review program, but also the dedication of the talented CDRH career staff in carrying out our public health mission and continuing to drive forward critical program enhancements.

#medicalindustrialcomplex #FDA #510k - odtmag.com

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