What in the World is the FDA’s Lab Accreditation Program – ASCA?

In this episode, our hosts are joined by Lisa Olson (NAMSA’s Vice President of North American Lab Services) to discuss the U.S. FDA’s new Accreditation Scheme for Conformity Assessment (ASCA). This pilot program, launched September 25, 2020 with a new guidance document, is designed to accredit laboratories for specific biocompatibility tests.

The U.S. FDA’s goal surrounding this new accreditation is to reduce the regulatory burden on the medical device industry through consensus of requirements for efficiency. This will also lead to decreased paperwork and timelines for certain regulatory submissions.

Although ASCA certification is not specific to the device manufacturer, unless they have an in-house laboratory, it is important for manufacturers to understand what ASCA is, its implementation and how important it may be when selecting a laboratory testing facility in the future.

“For the first time in medical device regulation history in the U.S., the U.S. FDA is going to accredit laboratories.” – Sheri Krajewski-Bibins

“If things were inconsistently reported by different laboratories, they [the U.S. FDA] had the responsibility to ask things. So if you can imagine them having to ask the same type of question on a basic cytotox assay for example, how much extra work that created because they [the U.S. FDA] can’t just assume it was done correctly?” – Lisa Olson

“They [the U.S. FDA] certainly won’t have to in all cases, review the complete testing report anymore.” – Don Pohl

“There’s the founding basis that you have a robust quality system, and that is the basis of the whole 17025 Certification. But now, the ASCA program ‘allows or requires’—however you want to look at it—you to get yourself [a lab] accredited to a certain test.” – Lisa Olson

“I could certainly see the benefit in trying to normalize that [training] across the industry.” – Don Pohl

“It’s an easier button, not an easy button, and manufacturers need to think about then do they go with labs that have no exposure to this program, simply because I think the Agency is going to use that [ASCA] in the background in how they are looking at data, no matter what it is.” – Lisa Olson

Discussion points include:

• When will the ASCA program be implemented?
• How does a laboratory qualify for the accreditation?
• How can manufactures capitalize on utilizing an ASCA laboratory for their biocompatibility testing?
• What are the potential challenges when implementing ASCA?

*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

Lisa M. Olson, MBA; Vice President, North American Lab Services, NAMSA

Lisa has over 20 years of medical device industry experience, including laboratory operations, R&D, service and market development and international standards development, as well as 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.

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 USFDA and other countries in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.