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BiocompCHATibility Podcast
Intact Skin Contact Devices: To Test or Not to Test

Intact Skin Contact Devices: To Test or Not to Test

BiocompCHATibility vor 5 Jahren

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40:41

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by Allison C. Komiyama,
Ph.D., 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FDA’s latest draft guidance, “Select Updates for Biocompatibility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 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 these types of 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draft, we’ve had many reviewers say “there’s a new draft
guidance, look at that”.”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