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FDA Clears > 80% of 510(k) Submissions Within 6 Months

June 23, 2011

An article on the web site this morning says that a new report has found that the U.S. Food & Drug Administration (FDA) took an average of 132 days to clear medical devices through the 510(k) process in 2010, compared to the average of 96 days it took in 2006.

Specifically, the report found that, between January 1, 2006, to May 23, 2010:

  • More than 53 percent of 510(k) submissions were cleared within 3 months.
  • More than 80 percent of 510(k) submissions were cleared within 6 months.

According to Chris Schorre, the vice president for global marketing for Emergo, the company that issued this report, “One possible explanation may be that FDA reviewers are requesting more clinical performance data from a higher percentage of manufacturers submitting 510(k) applications.”

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