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FDA Thoughts On Chemical Characterization

FDA Thoughts On Chemical Characterization

BiocompCHATibility vor 4 Jahren

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Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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 here

FDA’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.