Tuesday, June 24, 2008

FDA Claims Faster Device Approvals

Filed under: Society

The FDA's Office of Device Evaluation has released a report of its activities for fiscal years 2006 and 2007. Among other things, the FDA is claiming that its approval process has been expedited, allowing for faster answers to device approval applications.

Pharmalot reports:

In a new report, the agency maintains it is now faster at approving applications than in 2002. In fiscal 2006 the FDA, on average, took 335 days to approve the devices, which range from X-ray machines to syringes, compared with 438 days in 2005, Reuters writes.

But approval of devices under a separate, abbreviated “510K” application process required, on average, 95 days in 2006, compared with 87 days in 2005. Nonetheless, the FDA argues “the average review time from receipt to final decision has declined” since Congress passed a law overhauling device regulations in 2002. Approval data for fiscal 2007, which ended last Sept. 30, was not yet available.

More from Pharmalot..

FDA Office of Device Evaluation report: Part 5 - Key Performance Indices

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