BiocompCHATibility BiocompCHATibility

In this episode, our hosts are joined by Charles Ducker, PhD (NAMSA's Senior Director of Analytical Services) who recently returned from Korea, where he provided training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Throughout this discussion, we review the use of the standard and how it is adopted by Korean authorities. We also explore the challenges that lie ahead for device developers and testing labs.
“I think they [MFDS] were maybe surprised at the complexity. Laying out the information you have on your materials and the knowledge that you already have that may not lead to doing testing.” – Dr. Charles Ducker
“They were interested in how to apply ISO 10993-1 and how you apply ISO 10993-18 to the standard. And they want to know how to assess whether a laboratory has conducted the test appropriately.” – Dr. Charles Ducker
“One of the things I thought was very interesting… around Part 18, was what is different now versus the outdated version, and what changes came about. We had a lot of discussion about what is required and one of the big ones was AET [Analytical Evaluation Threshold] and how we calculate it.” – Dr. Charles Ducker
“Also, about how we qualify methods, what components go into that and what data you have to have behind the scenes to support the fact that your methods are appropriate for the intended use.” – Dr. Charles Ducker
Topics include:
Korea’s current position with the use of ISO 10993-18Qualification of a laboratory for chemical characterization testingSolvents and temperatures, and the justifications for each

On the latest installment of the BiocompCHATibility podcastis episode, our hosts are joined by Dr. Phil Smiraldo for his third feature3-peat episode on the podcast.
The conversation throughout this episode focuses and we discuss on the new recently published FDA biocompatibility guidance document —issued onn 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 fineprint.The Addition of Appendix G and how it can be utilized.A general overview of other changes by the FDA from their previous document.

In this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introduce
a new podcast to the NAMSA family, and talk a little bit to the hosts about the insightful
topics to come.
This new, conversational podcast will feature a new set of hosts who dedicate each
episode to trending regulatory and quality affairs topics within the MedTech industry.
Future topics include:
Refuse to Accept Policy for 510(k)s – This episode will delve into the procedures
and criteria FDA intends to use in assessing whether a premarket notification
(510(k)) submission meets a minimum threshold of acceptability and if it should
be accepted for substantive review.
FDA Releases Draft Guidance: Content of Premarket Submissions for Device
Software Functions – As a follow-up to one of NAMSA’s recent blog posts, our
hosts will describe information that the FDA deems important during its
evaluation of the safety and effectiveness of device software with one or more
device functions.
Compliance Pitfalls (Start-up Focus) – This episode will focus on common
compliance obstacles faced when dealing with documenting procedures,
complaint handling processes, supplier controls, audit & training, laboratory
controls, monitoring and calibration and more.

In this episode, Dr. Phil Smiraldo (NAMSA’s Senior Toxicologist) joins us to discuss the test article and the many challenges with identification and preparation. Throughout this discussion, we explore the many different types of test articles and help define what is considered patient contact and what is not? We also review how you can best work with your laboratory to define your test article preparation and make certain the test article definition is clear to the regulatory agency
Listeners can expect to learn:
How to easily define their test articleKey points to consider when separating patient contacting and non-patient contacting devicesThe risks of including non-patient contacting components in an extract
“One of the things we thought we’d elaborate on today is how do I define my test article.”
-Sheri Krajewski
“We are not going to jump into the GLP regulations and jump into that definition, but we
will help define the test article as it relates to biocompatibility.”– Don Pohl
“I’ve even worked through a scenario for a particular device where the customer in fact
came onsite to help take it apart.” – Phil Smiraldo
“This stuff [prep instructions] needs to be written down clearly so anyone can follow.” –
Don Pohl

In this episode, our hosts are joined by NAMSA Associate, Dr. Darin Kent, and second-time guest, Dr Ted Heise, to discuss the new paper released by the FDA and the American Chemical Society. The intention of this latest FDA publication is to examine specific topics that promote continuous discussion around the disparities between where the industry currently stands and how alignment and proper development may occur.
Listen in as these industry experts explore the topics covered by the FDA within this document, as well as the challenges faced by medical device manufacturers and testing laboratories regarding chemical characterization testing. They also examine how the FDA fared in the attempt to answer many industry questions.
Discussion points include:
Thoughts on where to go from hereFDA’s perspective on alignment in the industry“State-of-the-art” and where that has us today with the chemical characterization of medical devices
“The paper really is more about what is being done in devices and what is known about the work in devices.” – Ted Heise
“It’s striking really, the lack of literature out there about how these technologies and ideas could be used in an NTA [non-targeted analysis] type situation.” – Darin Kent
“There’s a fundamental need for basic research.” – Darin Kent
“In terms of giving solutions of how to deal with the challenges, I think it’s less true and part of that is simply that the state-of-the-art is just not well enough developed.” – Ted
Heise
“It provides arrows pointing to potential solutions.” – Darin Kent
“Does current state-of-the-art product devices that are safe or are there areas we have not uncovered yet?” – Don Pohl
“What we do better in characterizing medical devices has to bring additional value.” – Ted Heise
“One of the concerns is the level of burden that is imposed by the expectations wrapped up in this work.” – Ted Heise
You can access the full FDA publication for a fee through here: Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices.

In this episode, NAMSA’s Senior Product Development Specialist, Ed Arscott, joins our hosts to examine the relationship between packaging and biocompatibility, including: how to evaluate primary packaging for biological safety. The discussion also focuses on the direction provided in ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of
Medical Device Packaging Materials.
Listeners can expect to learn:
Where to look for guidance on packaging evaluation for medical devicesKey points to consider when looking at material contact to medical devicesEvaluating device/package interactionAssessing cases or primary packaging for reusable devices
“I’m happy to help join between the two realms of biocompatibility and packaging.” – Ed Arscott
“One common thing in the past was that you saw a lot of cytos being performed on primary packaging.” – Don Pohl
“The way that packaging interacts especially with implants; things can occur with packaging and implants that relate directly to product safety.” – Ed Arscott
“Part of figuring out what to do or not to do is based on device/packaging interaction.” – Don Pohl
“Let’s discuss metal trays for instruments; A form of packaging to evaluate as well.” – Sheri Krajewski
“Your level of evaluating for the packaging shouldn’t exceed the evaluation of your device.” – Don Pohl