New FDA Biocompatibility Guidance – Let’s Discuss

Operating room with monitor

Published:

Content Type:

Audio

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.


On the latest instalment of the BiocompCHATibility podcast, our hosts are joined by Dr. Phil Smiraldo for his third feature on the podcast. The conversation throughout this episode focuses on the recently published FDA biocompatibility guidance document—issued on September 7, 2023.

“My favorite nuance is that annex A has slightly been updated because now the X’s and O’s are almost all gone.” – Don Pohl

“Of these materials, you touch them every day, and your clothes are made out of them… Why would we need to do biocompatibility testing as a device? At a high level, that is what [Attachment G] says.”  – Don Pohl

“There are a few caveats, such as devices made for neonates… they are going to want to see the data. And similar type wording for pregnant woman.” – Phil Smiraldo

“We are not saying it’s never possible, but you’re going to have to really convince us if you only look at Part 1 and not our guidance” – Sheri Krajewski-Bibins

“One thing that I do like about this FDA document is it uses the same language from the ISO 10993 series.” – Phil Smiraldo

Discussion points include:

  • Verbiage updates to legally market devices and the fine print
  • The Addition of Appendix G and how it can be utilized
  • A general overview of other changes by the FDA from their previous document

*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.

Phillip Smiraldo, PhD, DABT

Phillip Smiraldo, PhD, DABT

Phillip holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications, and has provided several oral presentations. Dr. Smiraldo's timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position as Toxicologist, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies.  Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.

Sheri Krajewski

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.

Don Pohl

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the pre-clinical 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.