TÜV SÜD, a global partner offering a portfolio of testing, certification, auditing, and advisory services, recently announced its acceptance into the U.S. Food and 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,” said 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.