When it comes to medical device development, regulatory compliance is essential. In the United States, the Food and Drug Administration (FDA) is responsible for regulating medical devices and, specifically, their Accreditation Scheme for Conformity Assessment (ASCA Program) provides accreditation to laboratories that assess medical devices for compliance with regulatory requirements.
Initiated as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), 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).
NAMSA, the medical device testing pioneer and global marketplace leader for reliable testing services, received full accreditation to ASCA in July 2021. This accreditation recognizes NAMSA’s expertise in assessing medical device regulatory compliance for biocompatibility testing. This accreditation ultimately helps MedTech Sponsors accelerate development timelines and streamline FDA review timelines through the elimination of testing redundancies, creation of biocompatibility efficiencies, and the delivery of trusted test reports.
Annual Report
In 2022, the FDA published their ASCA Annual Report, which provides insights into the performance of ASCA-accredited organizations and related regulatory submissions. One of the key takeaways from the report was that one biocompatibility submission was made in 2022 with no findings (NAMSA). NAMSA’s ASCA summary reports met all FDA expectations and requirements—a testament to our expertise and the effectiveness of the ASCA accreditation.
In addition to meeting regulatory requirements, NAMSA places a strong emphasis on the MedTech Sponsor experience. The Client performing the ASCA testing program reported having a favorable experience with not only NAMSA, but also the FDA. This was the expected outcome when the FDA sought to establish the program. This Client stated, “There were no issues with the FDA and we received a premium service from NAMSA with expected timelines that exceeded our expectations.”
NAMSA’s experience with the ASCA accreditation program and continued relationship with the FDA highlights the importance of regulatory compliance in medical device development. NAMSA’s expertise in assessing medical devices for biocompatibility, coupled with our focus on the Client experience, has made us a trusted partner for medical device companies around the world.
Learn More
To learn more about the many benefits of working with an ASCA accredited laboratory, please click here. Or, to secure a complimentary consultation with one of our medical device testing experts, please visit: https://namsa.com/namsa-expertise/subject-matter-experts/.
Sheri Krajewski
Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s Biological Safety Consulting business. Additionally, she created the much sought-after NAMSA Training Series (NTS) for the iological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.