FDA and NAMSA Present: Reducing Regulatory Burden and Streamlining FDA Review through ASCA Pilot Program Utilization
Join NAMSA and the U.S. Food and Drug Administration (FDA) as we present this webinar regarding the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA.
The ASCA Pilot Program helps device manufacturers clear the important conformity assessment hurdle for medical device submissions presented to the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). This voluntary program is intended to: 1) enhance the FDA’s confidence in test methods and results; 2) decrease the need for additional information related to conformance with a standard; and 3) promote consistency, predictability and efficiency in medical device reviews.
During this webinar, the FDA will highlight how the ASCA Pilot Program streamlines aspects of conformity assessments for medical device submissions, as well as what manufacturers can expect when they submit ASCA test results to the government agency.
Join us as we answer the following questions:
- What are the benefits of participating in the ASCA Pilot Program?
- How does ASCA work, and what does the FDA expect from a submission with ASCA testing?
- What difference will ASCA make in submission development and overall process?
- What submission types and devices are eligible for the ASCA Pilot Program?
- Where do I find additional ASCA resources?
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