SOURCE: Underwriters Laboratories

February 20, 2007 15:59 ET

UL Was FDA's Top Third-Party 510(k) Premarketing Submission Reviewer for the Fourth Year in a Row

NORTHBROOK, IL -- (MARKET WIRE) -- February 20, 2007 -- Underwriters Laboratories Inc. (UL), a world leader in product safety testing and certification, announced today that UL's Medical Devices Business Unit conducted more 510(k) reviews in 2006 than any other Accredited Person on behalf of the U.S. Food & Drug Administration (FDA).

In 2006, UL was responsible for 27 percent or 64 of the 238 FDA third-party SE (substantially equivalent) decisions rendered on medical devices, an all-time high for the program. This performance positions UL as the Third Party Reviewer with the most SE Decisions since the inception of the program.

"UL's leadership in the 510(k) Third Party Program in 2006 is another example of the continuing commitment UL offers as an end-to-end partner in the US and Global regulatory process," said Anil Patel, General Manager of UL's Global Medical Business Unit. "UL's success in this service is a great example of how government and industry can establish new processes to help medical device manufacturers get their products to market in a timely manner."

UL is accredited to review 510(k)s for all devices eligible for the Accredited Persons Program. This includes devices such as catheters, x-ray machines, CT/MRI scanners, medical lasers, diagnostic ultrasound units and many other surgical and diagnostic devices.

"UL is proud of its leadership role in supporting the FDA's mission to ensure that medical devices are safe and effective for patient use," said Harvey Rudolph, Ph.D., Global Program Manager, Medical Devices. "UL has 510(k) experts worldwide who are able to communicate with customers in their local language to expedite the review process within a guaranteed turnaround period so that manufacturers can bring their products to market more quickly."

The FDA's national programs to protect public health in the fields of medical devices and radiological health are developed and implemented through the Center for Devices and Radiological Health (CDRH). CDRH reviews and evaluates medical device pre-market approval (PMA) applications, exemption requests for investigational devices (IDEs), and pre-market notifications, also known as 510(k)s.

"A shorter review process means faster time-to-market, and as a recognized 510(k) third-party reviewer, the FDA must rule on UL's recommendation within 30 days, much faster than they are required to respond to a direct submission to the Agency," said Rudolph. "With complete document packages, a UL 510(k) review will ordinarily receive a decision from the FDA in less than 45 days from the date the 510(k) is submitted to UL for review, which is about half the time it would take for a direct submission to the FDA -- time that can make a tremendous difference in the competitive global marketplace."

A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

Manufacturers must submit a new 510(k) when introducing a device into commercial distribution for the first time, proposing a different intended use for a medical device from that which they already have in commercial distribution, or if they wish to modify a device already on the market in a way that could significantly affect its safety or effectiveness.

Medical device makers seeking integrated channels for global compliance and multiple-market access can integrate their 510(k) review application with other regulatory services for compliance. UL specialists have decades of experience with the FDA and medical device industry, and have contributed to the development of the 510(k) third party review program.

The majority of medical devices are cleared through the premarket notification process. Although UL is accredited to review a manufacturer's 510(k) information and to offer an opinion to the FDA, it is still the manufacturer's responsibility to determine the device classification and prepare the 510(k) package.

To learn more, 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.

Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product safety certification organization that has been testing products and writing Standards for Safety for more than 110 years. UL tests more than 19,000 types of products annually, and more than 20 billion UL Marks appear on products each year. Worldwide, UL's family of companies and its network of service providers include 66 laboratories, and testing and certification facilities.

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