On April 12th, 2021, Eurofins E&E North America, an accredited ISO/IEC 17025 test laboratory, achieved ASCA recognition by the U.S. Food and Drug Administration (FDA), for Premarket Testing of Medical Devices.
Launched on September 25th, 2020, the voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program was devised to enhance consistency and predictability in the FDA’s approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for medical device premarket reviews.
The ASCA-accredited Eurofins E&E laboratories are strategical located within the United States: Austin (TX), Baltimore (MD), and Union City (CA). The accreditation confirms that each of these locations comply with the required qualifications specified under the ASCA scheme, so medical device manufacturers can undergo safety and performance testing according to ANSI/AAMI 60601-1 Part 1 and IEC 61010-1, for their 510(K) Premarket notifications as well as other medical device premarket reviews.
“We are excited to be part of the inaugural group of FDA ASCA-accredited testing laboratories” said Nimer Al-Hafi, President of Eurofins E&E North America. “Throughout its development, the program displayed invaluable advantages for medical device stakeholders, especially manufacturers, promoting confidence and supporting the effectiveness of the medical device testing process for the benefit of patients and end-users”.
This is an exciting time for Eurofins, as the ASCA accreditation coincides with another important milestone. On April 8th, 2021 Eurofins Expert Services Oy (No. 0537) became designated as Notified Body under the new Medical Device Regulation 2017/745 (MDR), for an extensive range of medical device technologies1.
Alongside the MDR Notified Body certification services, Eurofins provides a comprehensive suite of medical device testing solutions, including EMC, Safety and Wireless for medical device manufacturers looking to gain global market access and achieve regulatory compliance.
For more information about E&E’s FDA ASCA accreditation, please reach out via email or visit our website.
1 The scope of designation for Eurofins Expert Services Oy is available online, on the NANDO website (New Approach Notified and Designated Organisations), the European Commission’s information system.