FDA and ISO 10993-18:2020

In this bonus episode, our hosts discuss the new FDA Supplementary Information Sheet (SIS) on ISO 10993-18:2020 and their extent of recognition. On July 6, 2020 the FDA released this document to help clarify how manufacturers should utilize ISO 10993-18:2020 for U.S. regulatory submissions. However, with this release may come more questions than answers, so we decided to try to clarify this document and highlight items that have the most impact on manufacturers and their upcoming FDA submissions.

“There’s certainly a lot to recognize or not recognize when it comes to part 18.” – Don Pohl

“What you’re hoping to see…there is something that states complete standard {..} in this instance that is not the case.” –Don Pohl

“If we were betting people, we were betting this {table} would not be recognized by the FDA.” – Don Pohl

“Overall, I don’t see these {extent of recognition} as being huge show stoppers for anyone.” – Don Pohl

Discussion points include:

• What is an SIS and how is it helpful?
• What does partial recognition really mean?
• How do these changes impact ongoing chemical testing?
• What are the 5 main parts not recognized and what does this mean for manufacturers?

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 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.