Global Regulatory Pulse

The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval

In FDA, Regulatory by Melissa_Cadaret

ASCA is the Accreditation Scheme for Conformity Assessment (ASCA), which was created by the United States 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).

When the FDA announced intention to implement a pilot program for ASCA, NAMSA became immediately involved providing feedback on the program as early as May 2017, and participating as a guest panelist during the public workshop held on May 23, 2018. With the recent release of the draft guidance entitled “Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff” on September 20, 2019, NAMSA completed review and drafted comments for submission under the 90-day comment period.

Through our work with thousands of medical device clients, NAMSA recognizes 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 Based on the requirements in the draft guidance, the pilot program should eliminate these variations and provide efficiencies fulfilling the FDA objective. We are hopeful at this time that the additional accreditation responsibility added to the testing laboratory, accrediting body, and the device manufacturer will be mutually beneficial.

Lastly, we recognize that the FDA has set high-quality and scientific requirements of testing laboratories seeking accreditation.  NAMSA is positioned well for the pilot with ISO 17025 accreditation and our rich scientific foundation with more than 50 years of medical device experience.  We believe in collaborating with our clients to provide superior results while adhering to our core culture of quality.

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.

NAMSA Test Navigator
NAMSA’s Test Navigator was built to provide visibility into the breadth and depth of NAMSA’s testing capabilities. It highlights the most commonly used tests within the medical device industry and also provides thousands of unique testing services for special test and study requirements. No matter your testing goals, NAMSA can deliver a personalized, reliable and cost-effective solution for your development efforts. Access now!

Authors:

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.