As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).
The purpose of the ASCA program is to reduce the regulatory burden on the medical device industry through consensus of requirements for efficiency. Ideally, the ASCA “stamp of approval” would clear the first hurdle in the medical device premarket regulatory process for manufacturers submitting to the Centers for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
On September 25, 2020, the FDA issued three final guidance documents with a series of informational webinars for both accreditation bodies and laboratories. The FDA will conduct training in November and December accordingly, and U.S. laboratories can submit for accreditation review once accreditation bodies have been identified. Following training, the FDA is expected to release an initial list of ASCA-approved laboratories, although specific timing is undetermined at the time of this blog.
What Does this Mean for Industry?
Through NAMSA’s work with thousands of medical device clients, we recognize that there are variations in test methods, parameters and report styles among the CRO community and that these can contribute to delays in the FDA review process. Based on the requirements in these new guidance documents, the pilot program should eliminate these variations and provide efficiencies to fulfill FDA objectives. We are hopeful that the additional accreditation responsibility added to the testing laboratory, accrediting body, and the device manufacturer will be mutually beneficial.
How Can NAMSA Help?
NAMSA is the industry pioneer of medical device testing to drive successful regulatory outcomes. We offer all testing services in our state-of-the-art laboratories located throughout North America, Asia and Europe, and are continually committed to looking for ways to save clients time and reduce the overall amount of testing.
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Melissa Cadaret is the Director of Global Compliance and Process Improvement at NAMSA. Her past experience includes serving as the Director of Analytical Services and Biocompatibility Laboratory Operations and Site Leadership for NAMSA’s Global Headquarters in Northwood (Toledo), Ohio. With more than 15 years of biocompatibility experience, Melissa is also currently a U.S. Expert on ISO TC 194: Biological Evaluation Medical Devices ANSI / AAMI/ ISO 10993. Melissa has a MS in Molecular Biology from Bowling Green State University and Bachelor’s degree in Biology from Southern Illinois University.