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UL Achieves ASCA Accreditation for Medical Device Testing from the U.S. Food and Drug Administration

The accreditation supports greater predictability for manufacturers in FDA medical device clearance processes and more consistent and efficient FDA assessments of medical device safety and performance testing to reduce risks to public health.

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April 13, 2021

Northbrook, Illinois, April 13, 2021 – UL, the global safety science leader, has received designation as an accredited  ISO/IEC 17025 laboratory under the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA), a voluntary pilot program for medical device safety and performance testing.

The FDA ASCA program targets medical device manufacturers undergoing 510(k) premarket notification and other regulatory reviews required in order to sell their devices on the U.S. market. The FDA created the ASCA program to support more efficient FDA evaluation of manufacturers’ compliance with voluntary consensus standards. By utilizing ASCA-accredited laboratories such as UL for their device safety and performance testing, manufacturers may decrease the likelihood of delays or questions from the FDA as their devices undergo review.

Key benefits of participating in the FDA ASCA program include increased confidence in testing results obtained from accredited laboratories; greater predictability for manufacturers in FDA medical device clearance processes; and more consistent and efficient FDA assessments of medical device safety and performance testing to reduce risks to public health.

“Building in more predictability and consistency in medical device safety and performance testing and regulatory review is crucial for helping medical device companies achieve access to the U.S. healthcare market with fewer delays and lower likelihood of having to retest or provide additional information to the FDA,” said Pamela Gwynn, Principal Engineer in UL’s Medical Device Testing and Conformity division. “UL realizes that the FDA ASCA program can help manufacturers establish greater trust and confidence from regulators as well as patients and users in their devices’ safety and performance claims, and we are excited to enlist our international network of testing laboratories in this effort.”

UL offers ASCA-accredited laboratory testing of medical devices at nine locations:  Brea, California; Fremont, California; Mounds View, Minnesota; Northbrook, Illinois; Melville, New York; Research Triangle Park, North Carolina;  Neu Isenburg, Germany; Warsaw, Poland; and Ise-Shi Mie-Ken, Japan.

About UL

UL is the global safety science leader. We deliver testing, inspection and certification (TIC), training and advisory services, risk management solutions and essential business insights to help our customers, based in more than 100 countries, achieve their safety, security and sustainability goals. Our deep knowledge of products and intelligence across supply chains make us the partner of choice for customers with complex challenges. Discover more at UL.com.

For information about Standards development and other nonprofit activities, visit UL.org.

Press Contact:

Steven Brewster

[email protected]

+1.847.664.8425

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