Full article reprinted from "The Gray Sheet" - May 25, 2009
FDA's device center has seen a big drop-off in 513(g) requests since a new user fee put a hefty price tag on the voluntary product classification queries. Find out more...
FDA's device center has seen a big drop-off in 513(g) requests since a new user fee put a hefty price tag on the voluntary product classification queries.
Before the user fee went into effect in fiscal year 2008, 513(g) filings had been increasing steadily - from four in 1990 to 364 in 2007. Firms saw the free requests as a way to find out whether a device was exempt from 510(k) requirements without paying 510(k) or PMA user fees, the agency says.
Since 2007, FDA has seen a 70% drop-off in the voluntary filings. Only 111 requests were received in 2008, some of which may not have been reviewed due to lack of payment, 513(g) coordinator Diane Garcia says.
The standard user fee for 513(g) requests is $2,710 in FY 2009; the standard 510(k) fee, by comparison, is $3,693.
Industry Unwilling To Pay Double
Section 513(g) of the Food, Drug & Cosmetic Act lets companies formally request FDA's opinion on the likely classification of a device, and receive a written response within about 60 days.
Most companies use the filings to inquire whether a product is an FDA-regulated device; whether it is exempt from 510(k) requirements; whether a new 510(k) is needed for a device modification; or what the best regulatory route is for a new technology or a new intended use, according to FDA.
If FDA says the product seems to require a 510(k) or PMA, the company will end up paying twice.
"It appears that industry is not willing to pay two user fees to get the classification for a specific device type," noted Lawrence Romanell, an FDA health scientist and leader of the CDRH Matrix network for regulatory affairs and special interests.
Most often, and particularly for 513(g) requests related to software products, the agency determines that the device is not exempt and a 510(k) should be submitted, Romanell explained in a CDRH Web presentation on the 513(g) process.
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