FDA makes 510(k) easier

WASHINGTON - Manufacturers are generally hailing passage of a new law that should expedite marketing clearance of new products at the FDA. Signed into law Oct. 26, the Medical Device User Fee and Modernization Act of 2002 establishes a user's fee program for medical devices and a third party inspection program to hurry up access to safe and effective medical devices. Under the user fee program, the manufacturers would pay fees for FDA review of device applications. The agency would use those fees to improve timeliness, quality, and predictability of reviews, particularly for breakthrough technologies. Under the third party inspection program, manufacturers with a good compliance history would be permitted to select an FDA-accredited, non-government entity to perform quality systems inspections. The FDA currently performs these inspections. Such a program should increase inspections of device firms and permit FDA to focus its inspection resources on firms with greater problems and devices that pose greater risks. Getting product to market faster is a bone of contention for some manufacturers. Although Tiara Medical Systems breezed through its last 510(k), its previous 510(k) submission got bogged down in a grueling nine month process. Geoff Sleeper, v.p. of R&D at Tiara, admits that his company was partly at faulty for the lengthy gestation but welcomes any measure that speeds up a return on investment. "If you can get it to market faster, you can recoup those costs," he said. "You can't recoup anything if you can't market it." HME