UL Extends Two-Week Turnaround Guarantee on FDA 510(k) Third-Party Submissions
May 23, 2007 // Published as a news service by IHS
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Underwriters Laboratories (UL) announced the extension of its two-week guaranteed turnaround for UL reviews under the U.S. Food and Drug Administration (FDA) Third Party 510(k) review program. UL was the top FDA 510(k) Third Party reviewer in 2006.
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.
According to UL, the extension of the guarantee will continue through the end of 2007 and coincided with the addition of medical devices testing expert Ned Devine to the UL Medical Business Unit team as senior staff engineer.
Devine began his career as a project engineer with UL from 1979 to 1984. He spent the next 23 years 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 served as primary or supervisory reviewer for more than 150 of the 510(k)s cleared through the FDA.
Additional information on UL Third Party Review program is available on the UL web site at http://www.ul.com/hitech/medical/.
Source: Underwriters Laboratories (UL).