SOURCE: Underwriters Laboratories

April 20, 2007 11:42 ET

Update: Underwriters Laboratories Extends Two-Week Turnaround Guarantee on FDA 510(k) Third Party Submissions for Medical Device Conformance Testing

NORTHBROOK, IL -- (MARKET WIRE) -- April 20, 2007 -- Underwriters Laboratories (UL), a world leader in product safety testing, certification and management system registrations, recently announced the extension of its two-week guaranteed turnaround for UL's reviews under the U.S. Food and Drug Administration (FDA) Third Party 510(k) review program. Earlier this year, UL announced its position as the top FDA 510(k) Third Party reviewer for 2006.

The extension of the guarantee will continue through the end of 2007 and coincides with the recent addition of medical devices testing industry veteran Ned Devine to the UL Medical Business Unit team as Senior Staff Engineer who brings to his new role at UL more than two decades of experience in international medical services engineering including the FDA 510(k) Third Party program.

Devine began his career as a project engineer with UL from 1979 to 1984. He spent the next 23 years in increasingly responsible positions consulting and working in product safety engineering, standards development, international compliance, auditing and program management positions. He has been involved in the FDA 510(k) Third Party program since its inception in 1996 and has served as primary or supervisory reviewer for over 150 of the 510(k)s cleared through the FDA.

"In our ongoing effort to meet customer demand and provide end-to-end regulatory solutions for medical device companies globally, we realize time-to-market is a key factor for both manufacturers and users of devices," said Anil Patel, General Manager, UL's Medical Business Unit. "To facilitate this, we are pleased to welcome Ned Devine back to UL in conjunction with the extension of our popular two-week guarantee."

The two-week turnaround guarantee applies to all eligible, non-pilot devices and is contingent upon receiving a full documentation package at the time of submittal. The guarantee pertains to the time period for UL to submit the recommendation to the FDA, which is then legally required to respond to the third party within 30 days. The FDA has 90 days to respond to a submission made directly to the agency.

For additional information on UL's Third Party Review program visit www.ul.com/medical. For business inquiries, contact Tara Kambeitz, Marketing Manager, Medical Business Unit, 1-877-ULHELPS (1-877-854-3577) ext. 55610 or Tara.L.Kambeitz@us.ul.com or Ned Devine by e-mail at Ned.Devine@us.ul.com.

Underwriters Laboratories (UL) is an independent, not-for-profit product safety certification organization that has been testing products and writing Standards for Safety for over a century. UL evaluates more than 19,000 types of products, components, materials and systems annually with 21 billion UL Marks appearing on 71,000 manufacturers' products each year. UL's worldwide family of companies and network of service providers includes 66 laboratory, testing and certification facilities serving customers in 104 countries. For more information, visit: www.UL.com.