The U.S. Government Accountability Office has issued the results of a study (pdf) showing the time from submission of 510(k)s to final decision from FDA has "increased substantially in recent years."
From fiscal year 2005 through FY 2010, the average time to final decision for 510(k)s increased 61 percent, from 100 days to 161 days. The time to final decision includes the days FDA spends reviewing a submission as well as the days FDA spends waiting for a device sponsor to submit additional information in response to a request by the agency.
GAO acknowledged that FDA is taking a number of steps to address this and other issues related to review time and meeting performance goals identified in the report, and advised the agency to "monitor the impact of those steps in ensuring that safe and effective medical devices are reaching the market in a timely manner."
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