While review times for 510(k) submissions at the US Food and Drug
Administration (FDA) have increased more than 55% since 2005, agency
officials say the slower review is due to poor quality submissions by
device makers. FDA this week released an internal analysis of increasing
review times, confirming industry claims that the time has gone up
dramatically in the last five years. FDA’s analysis shows that the
average decision time for a 510(k) submission increased from 90 days in
2005 to 140 days in 2009. According to the report, 83% of submissions
had problems in at least one of the following areas: inadequate device
description, discrepancies throughout submission, problems with
indications for use, failure to follow or otherwise address current
guidance document(s) or recognized standards, or missing performance
testing and required clinical data for certain devices.
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