On July 23, 2021, NAMSA became the first-ever biocompatibility laboratory to be accredited by the FDA to the ASCA Pilot Program. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.
The ASCA Pilot Program clears the first hurdle in the medical device premarket regulatory process for manufacturers submitting for clearance or approval to the FDA’s Centers for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
This webinar will discuss the ASCA Pilot Program, provide guidance tools and help manufacturers understand the process and responsibilities for all medical device testing stakeholders. This online event, 60 minutes in length, will also allow time for Q&A with our testing experts.
Join us as we answer the following questions:
- What is ASCA accreditation?
- What are the benefits of working with an ASCA-accredited biocompatibility laboratory?
- What are ASCA testing report responsibilities/requirements for manufacturers when submitting to the FDA for premarket approval?
- What are exclusion and inclusion criteria when performing ASCA testing?
- Where do I find additional FDA ASCA resources?