News | April 29, 2021

TÜV SÜD North America Gains U.S. FDA (Food & Drug Administration) ASCA Accreditation For Medical Device Testing

WAKEFIELD, MASS.--(BUSINESS WIRE)--

TÜV SÜD, a trusted global partner offering a comprehensive portfolio of testing, certification, auditing, and advisory services, recently announced their acceptance into the Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for medical device safety and performance testing. As a designated ASCA accredited laboratory, TÜV SÜD’s North American laboratories are authorized to perform premarket testing for device manufacturers seeking entry into the U.S. market.

For the first time in history, the FDA has created a carefully selected list of approved laboratories, all of whom have demonstrated compliance with these set standards and the periodic auditing process that is required for accreditation.

The FDA has launched the ASCA Pilot Program intentionally to increase consumer confidence in the test results provided by authorized testing laboratories. The program also aims to promote consistency and predictability throughout the premarket review process, and to encourage international harmonization.

The ASCA Pilot Program does not introduce new requirements for medical device manufacturers, but rather communicates clear expectations for how ASCA-accredited testing labs must present premarket results.

By utilizing an FDA ASCA-accredited laboratory like TÜV SÜD for medical device basic safety and performance testing, manufacturers can experience a faster, more efficient review process from the FDA.

“The ASCA pilot program is a great example of the FDA taking further steps to collaborate with the medical device industry, and we’re delighted to be recognized as a trusted partner capable of meeting the high expectations of manufacturers and the FDA,” says TÜV SÜD’s North American Director of Medical and Health Services, Adam Menzies.

Currently, TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five locations: Minnesota, Massachusetts, California, Florida, as well as in Canada.

For more information regarding the ASCA Pilot Program of any of TÜV SÜD’s other services, please reach out barry.quinlan@tuvsud.com or visit our website www.tuvsud.com/en-us for additional information.

About TÜV SÜD
TÜV SÜD is a premium quality, safety, and sustainability solutions provider that specialises in testing, inspection, auditing, certification, training, and knowledge services. Since 1866, the company has remained committed to its founding principle of protecting people, property and the environment from technology-related risks. Headquartered in Munich, Germany, TÜV SÜD is represented in more than 1,000 locations worldwide. TÜV SÜD operates globally with a team of more than 24,000 multi-disciplinary experts recognised as specialists in their respective fields. By combining impartial expertise with invaluable insights, the company adds tangible value to businesses, consumers and the environment. The aim of TÜV SÜD is to support customers with a comprehensive suite of services worldwide to increase efficiency, reduce costs and manage risk. Visit www.tuvsud.com

About TÜV SÜD America
TÜV SÜD America Inc., a subsidiary of TÜV SÜD AG (Munich, Germany), is a leading globally recognized testing and certification organization. TÜV SÜD's Business Assurance division provides management system certification services to ISO 9001, ISO 14001, AS9100, Safe Quality Food (SQF), and more. TÜV SÜD's Product Service division offers electrical and mechanical product safety, Electromagnetic Compatibility (EMC) testing, environmental testing, NRTL and SCC certification, CE marking assistance, restricted substance services, international compliance services, and more. TÜV SÜD America also provides a comprehensive suite of services for the medical device sector as a European Union notified body for the medical device, active implantable medical device and in-vitro diagnostic device directives, and a complete service portfolio including ISO 13485 and MDSAP certification, FDA 510(k) and third-party inspections. The company's Industry Services division offers a full suite of services for pressure equipment manufacturers and materials producers exporting products to the European Community. The Industry Services division also includes TÜV SÜD Global Risk Consultants, the leading global provider of unbundled property loss control services. Visit www.tuvsud.com/en-us

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