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FDA says medical device reviews became faster
WASHINGTON (Reuters) - The U.S. Food and Drug Administration has become faster since 2002 at approving applications from makers of medical devices, according to an agency report released on Monday.
In fiscal 2006 the agency, on average, took 335 days to approve the devices, which range from X-ray machines to syringes, compared with 438 days in 2005, the report said.
But approval of devices under the agency's separate, abbreviated "510K" application process required, on average, 95 days in 2006, compared with 87 days in 2005.
Still, the agency said "the average FDA 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 September 30, was not yet available.
Lawmakers enacted the changes in part to help streamline the FDA's device-review process and to set review time goals for the agency. The 2002 law also allowed the FDA to levy fees on device makers to help pay for the review process.
Johnson & Johnson, Medtronic Inc, Baxter International Inc and General Electric Co's GE Healthcare are among the largest U.S. makers of medical devices.
As part of the changes, the FDA also set up third-party programs that allow independent companies to review device-maker applications before the agency makes the final decision.
While the report did not give specific 2007 data, it said 16 percent fewer, or 233, third-party reviewed applications were submitted compared with 278 in 2006. But that was before Congress amended the program last year to ease some restrictions. Critics of the third-party review program say the FDA should get more funding to do the reviews itself.
Overall, the FDA said it cleared 2,640 devices for use under its so-called "510K" process in 2007 compared with 2,677 devices in fiscal year 2006.
Device makers using the abbreviated "510K" process only need to show the agency their product is as good as similar ones on the market. For new types of devices, manufacturers must file a premarket approval application with more data to show the product is safe and effective. (Reporting by Susan Heavey; editing by John Wallace and Steve Orlofsky)
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