Intact Skin Contact Devices:

To Test or Not to Test

In this episode, our hosts are joined by Allison C. Komiyama, PhD, R.A.C., Owner and Consultant at AcKnowledge Regulatory Strategies and former U.S. FDA Reviewer, to discuss the U.S. FDA’s latest draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.” The U.S. FDA has determined the biocompatibility risk of various polymers and fabrics to be low based upon a safe history of use in medical devices for this categorization. Our hosts dive into the list of materials, as well as the nuances of this guidance, that will ideally help manufacturers with intact skin contact devices receive market access with fewer questions.

“There might be some unnecessary testing going on in some cases.” –Don Pohl

“The long history of safe use. U.S. FDA uses a lot of resources to not only review the tests themselves, but they mention they spend resources on review of rationale and justifications; and I think that may be harder than reviewing test reports.” – Allison Komiyama

“It was very exciting when we saw this guidance document. We all felt like this was a long time coming.” – Allison Komiyama

“Class VI testing might become useful again.” – Sheri Krajewski-Bibins

“People are going to be googling Type 4 Sensitivity to figure out what that is because its sitting on a label.” – Don Pohl

“I commend the biocomp group on this document.” – Allison Komiyama

“I was thinking about a device I’m reviewing right now. I look back at that device and it has stainless steel and aluminum, and if I look at all those polymers, I have co-polymers as well. If I look at this guidance now, I would be left wondering if I can apply everything here or am I going to have to do cyto, sensitization and irritation because I have metals and some co-polymers that aren’t necessarily defined.” – Don Pohl

“Guidance is U.S. FDA’s current thinking, and even if it is a draft, we’ve had many reviewers say ‘there’s a new draft guidance, look at that.’” – Allison Komiyama

Discussion points include:

• Complete overview of the guidance and implementation
• Inclusions and exclusions for materials and devices
• Submission guidelines when applying this guidance
• Information needed to submit for these types of devices immediately
• Precautionary labeling instructions that may be necessary

*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

Allison C. Komiyama, PhD, R.A.C; Owner and Principal Consultant, AcKnowledge Regulatory Strategies

Allison Komiyama is a former reviewer for the U.S. FDA who started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices. During her time with the U.S. FDA, Allison worked as a biologist and reviewer in the Office of Device Evaluation. She was a lead reviewer and consult on 510(k) Premarket Notifications, Pre-Submissions, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs (OSEL) in support of U.S. FDA recognized ISO and ASTM standards. After her time at the U.S. FDA, Allison worked as a project manager and regulatory affairs manager at an in vitro diagnostic device company, as well as a senior regulatory specialist and director of regulatory affairs at two consulting firms.

Allison has worked on a diverse range of devices, including orthopedic devices (spine, hip, knee, and other skeletal implants), bone void fillers, general hospital devices, urological devices, in vitro diagnostic devices, wearable technology, combination products, mobile medical applications and neuro-stimulating devices. She received her PhD in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. She received her Regulatory Affairs Certification (US) in 2014.

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.