NAMSA Awarded ASCA Accreditation

NAMSA is pleased to announce that the U.S. Food and Drug Administration (FDA) granted the organization  Accreditation Scheme for Conformity Assessment (ASCA) status on July 23. The ASCA Pilot Program, a first-of-its-kind assessment created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.

In this episode, our hosts are joined once again by Lisa Olson, NAMSA’s Senior Vice President of Global Laboratory Operations to discuss the importance of this accreditation and what it means to NAMSA. But perhaps most importantly, what this status means for manufacturers who choose to do their testing with ASCA accredited laboratories.

Discussion points include:

• What biocompatibility tests are included in ASCA accreditation?
• How can manufactures capitalize on utilizing an ASCA laboratory for their biocompatibility testing?
• What types of devices are disqualified from ASCA testing?
• What are the potential challenges when implementing ASCA?
• How do manufacturers “order” ASCA Testing? Is everything ASCA?

“It’s the first time the FDA has done this for a biocompatibility lab.” Sheri Krajewski

“I believe the FDA was really looking at the value of the tests. There are certain tests like cytotoxicity that are incredibly standardized. In essence, many labs are doing them the same.  The FDA did a great job of picking out the studies are well established and many labs know how to do them and have established protocols for them.”  Lisa Olson

“NAMSA is accredited for biocompatibility testing and people would say, aren’t you already? NAMSA has submitted biocompatibility testing for many years. Yes, we have. The difference here is the FDA has taken steps to pre-certify certain tests.”  Sheri Krajewski

“There might be for ASCA studies limited deficiencies and limited review time.  Hopefully none (deficiencies) for these (ASCA) studies.”  Don Pohl

“What you really care about is the data. And, by having these summary reports, you get rid of all the marketing part of it and some of the ‘fluff’ and get a clean report of results. I think it’s a great way to have both reviewers and labs focus on the most important part.”  Lisa Olson

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.

Meet the Speakers

Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She 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, Sheri created the much sought-after NAMSA Training Series for the biological 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.

Don Pohl; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the U.S. FDA and other global regulatory bodies in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.

Lisa M. Olson, MBA; Senior Vice President, Global Laboratory Operations, NAMSA

Lisa has over 20 years of medical device industry experience, including laboratory operations, R&D, service and market development, international standards development and executive leadership experience. She brings a multifaceted view to strategic growth and organizational transformation within highly regulated businesses. Lisa received her undergraduate degree in Microbiology from the University of Minnesota and her Masters of Business Administration from the University of St. Thomas.