TÜV SÜD Accepted into FDA Device Safety and Performance Testing Pilot
Medical device auditor and certifier, TÜV SÜD, has been accepted into the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program.
The pilot program is being conducted to increase public confidence in the test results delivered by authorized testing laboratories. It looks to encourage consistency and predictability in the premarket review process as well as international harmonization.
The company, which is headquartered in Munich, Germany, has received FDA designation as an ASCA accredited laboratory, which authorizes it to perform premarket testing for device makers looking to enter the U.S. market.