Intertek Granted ASCA Recognition by U.S. Food and Drug Administration for Premarket Testing of Medical Devices
13 Apr 2021
Chicago – Intertek, a leading Total Quality Assurance provider to industries worldwide, has been selected as an accredited testing laboratory under the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. With this recognition, 12 Medical Centers of Excellence within Intertek’s global network of labs are authorized to assist manufacturers around the world with medical device premarket testing to access the U.S market.
The ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results, allowing for greater consistency and predictability in the FDA's approach to conformity assessment. Following a two-step application and evaluation process, Intertek was granted accreditation for the program. As a recognized lab, the Company is approved to conduct assessments on medical devices for conformity to recognized consensus standards and test methods used in premarket reviews, delivering comprehensive test reports along with ETL Certification and CB Scheme Reports.
Sunny Rai, Senior Vice President at Intertek, commented: “At Intertek, our focus has always been on providing Total Quality Assurance solutions to our customers, helping them navigate the testing and certification process. This accreditation will help provide peace of mind to the industry and support the FDA’s continued public health mission. We are thrilled to build upon our years of experience and expertise to help decrease the burden of premarket submissions, making the process smoother and ultimately getting products to market as quickly and efficiently as possible.”
For more than 50 years, Intertek has been partnering with medical device manufacturers to provide Assurance, Testing, Inspection and Certification. The company's experts understand the latest technologies and the regulatory requirements that products must meet, including those for mobile health applications and software. With engineers and technicians at 12 Centers of Excellence and 23 labs across the world dedicated to testing medical devices equipped with state-of-the-art equipment, Intertek helps customers launch new medical devices to market quickly. For more information, visit www.intertek.com/medical.
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About Intertek
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Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.