New FDA Biocompatibility Guidance – Let’s Discuss

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 Charles Ducker“One of the things I thought was very interesting… around Part 18, was what is different now versus the outdated version, and what changes came about.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 DuckerTopics 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 SmiraldoDiscussion 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 introducea new podcast to the NAMSA family, and talk a little bit to the hosts about the insightfultopics to come.This new, conversational podcast will feature a new set of hosts who dedicate eachepisode 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 proceduresand criteria FDA intends to use in assessing whether a premarket notification(510(k)) submission meets a minimum threshold of acceptability and if it shouldbe accepted for substantive review.FDA Releases Draft Guidance: Content of Premarket Submissions for DeviceSoftware Functions – As a follow-up to one of NAMSA’s recent blog posts, ourhosts will describe information that the FDA deems important during itsevaluation of the safety and effectiveness of device software with one or moredevice functions.Compliance Pitfalls (Start-up Focus) – This episode will focus on commoncompliance obstacles faced when dealing with documenting procedures,complaint handling processes, supplier controls, audit & training, laboratorycontrols, 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 agencyListeners 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 wewill 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 factcame 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.” – TedHeise“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 HeiseYou 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 ofMedical 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

In this episode, our hosts are joined by NAMSA Toxicologist, Michelle Kelly, to discuss the ever-elusive biological equivalency claim. The discussion focuses on how to maintain the balance of the risk and benefit of a medical device without stalling innovation. We also explore equivalency and how it is not only a key concept to the risk analysis but also a challenging concept to prove.“This is often a controversial topic.” – Sheri Krajewski“You not only have to think about equivalency per 10993-1, but also think about it as one aspect of equivalency that is sitting in the MDR.” – Don Pohl“Equivalency is one of the key principles that sits in 10993-1.” – Don Pohl“To think of equivalence as a concept rather than an equation is the best thing to do.” – Michelle Kelly“We have that word “same” sneaking up on us. I can see that being interpreted differently by reviewers and regulators.” – Don Pohl“When we developed it [Annex C of 10993-18], we were trying to define toxicological equivalence to help out the working group writing 10993-17.” – Michelle Kelly Discussion points include:      Equivalence in the 10993 Series, including ISO 10993-18 Annex C      Equivalence under the MDR      Variances in the EU from one Notified Body to another      Challenges with demonstrating and establishing overall MDR equivalence      The concept of “same” and how it is interpreted by regulators

In this episode, our hosts are joined by the QB1 (or 4 of them) of GLP (Good Laboratory Practice), NAMSA’s Study Directors. Throughout this podcast, the team delves into the role of the Study Director in biocompatibility and chemical characterization studies, discussing day-to-day activities, legalities, key factors manufacturers should know about working with a Study Director, and the qualifications needed to be an effective Study Director.Discussion points include:GLP and what it means for biocompatibility studiesThe role of the Study Director in the GLP programThe history of adopting GLP guidance from pharmaceutical studies and how they transfer to medical devices“GLP is front and center when submitting to global regulators.” – Sheri Krajewski“GLP is for conducting non-clinical lab studies that support applications and submissions to regulatory bodies with the intent that these studies assure quality integrity of studies.” – Alison Shaffer“We wear a lot of hats both externally with our customers and with the labs.” – Brandon Hahnlen“We like to drive things. Not a lot of people know about this industry {and role of a Study Director} and a lot of us take a fortuitous route to get here.” – Theresa Ford-Wells“One exciting thing is seeing the variety of medical devices. It’s neat to see over the years the trends and types of devices coming that we get to work on prior to anyone knowing they exist.” – William Adamiak

In its third year, the North American Biocompatibility Summit (NABS) is a limited-seating event that provides industry insights and expertise sharing on the biocompatibility of medical devices. This year, sessions will include the latest regulatory updates, biological evaluation strategies, and best practices that lead to successful biocompatibility programs in 2021 and beyond. In this episode, our hosts discuss this upcoming event and what attendees can expect. This includes details on the NABS Scientific Advisory Board, abstract submissions, and how the Board determined what educational opportunities to offer. Listeners will learn more about featured topics, including the overall theme that emerged from the abstracts.“The topics are universal to all medical devices.” Don Pohl“We receive enough abstracts that we have more than enough to choose from and it’s interesting to see the trends in the industry of what people are struggling or dealing with.” Don Pohl“There are no cupcake topics at this event, that’s for sure.” Sheri Krajewski“It’s great to have this opportunity to get out and hear what everyone else is experiencing.” Don Pohl“This is not just a Minneapolis event; anyone from anywhere is welcome to join us.” Sheri KrajewskiDiscussion points include:What is the North American Biocompatibility Summit and how can one registerExpectations attendees can have from this event; from education to networking time.The topics of the event including chemical characterization, toxicological risk assessment and alternative test methodsRegistration details for the event

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.“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 protocolsfor 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-qualify 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 OlsonDiscussion 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?