NAMSA is excited to announce that on July 23, 2021, it received Accreditation Scheme for Conformity Assessment (ASCA) status from the U.S. FDA. This first-of-its-kind assessment created by the U.S. FDA, was initiated as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), and clears the first hurdle in the medical device premarket regulatory process for manufacturers submitting clearance or approval to the FDA’s (CDRH) and (CBER).
NAMSA, now the first and only ASCA-accredited biocompatibility laboratory in the United States, will provide medical device Sponsors added benefits throughout ASCA testing programs, such as:
NAMSA, now the first and only ASCA-accredited biocompatibility laboratory in the United States, will provide medical device Sponsors added benefits throughout ASCA testing programs, such as:
- Accelerated development timelines through pre-approved standard test methods
- Fewer expected, or no, FDA deficiency questions regarding ASCA test methods
- Delivery of high-quality, trusted test reports
- Decreased FDA submission review timelines
- Multiple biocompatibility program efficiencies
Medical Device Testing Resources
Founded in 1967, NAMSA was the first independent company in the world to focus solely on testing medical device materials for safety. Today, NAMSA conducts over 100,000 tests annually to assist medical device innovators meet global testing requirements, mitigate biological risks and ensure medical device safety for end users.
From this experience, we have created several resources to help manufacturers achieve efficiencies throughout testing programs and the full development continuum. We invite you to access one of our complimentary resources below:
- FAQs: ACSA-What's it all About?
- NAMSA Medical Device Testing Solutions and Services
- BiocompCHATibility Podcast Series
- Blog
- On-Demand Webinars
- NAMSA Training Series
- NAMSA e-Learning
+1 866.666.9455 (toll free)
+1 419.666.9455 (outside of USA)
+1 419.666.9455 (outside of USA)
To learn the benefits of working with an ASCA-certified laboratory, or to receive a quote, please fill out the form below. Additionally, more information on the FDA’s Consensus Standards and the Accreditation Scheme for Conformity Assessment (ASCA) Pilot may be found here.
