Global safety science company UL has received designation as an accredited ISO/IEC 17025 laboratory under the U.S. 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, officials say.
“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,” says Pamela Gwynn, principal engineer in UL’s Medical Device Testing and Conformity division.
She adds, “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, Calif.; Fremont, Calif.; Mounds View, Minn.; Northbrook, Ill.; Melville, N.Y.; Research Triangle Park, N.C.; Neu Isenburg, Germany; Warsaw, Poland; and Ise-Shi Mie-Ken, Japan.