FDA Thoughts On Chemical Characterization
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.
“The paper really is more about what is being done in devices and what is known about the work in devices.” – Dr. 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.” – Dr. Darin Kent
“There’s a fundamental need for basic research.” – Dr. 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.” – Dr. Ted Heise
“It provides arrows pointing to potential solutions.” – Dr. 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.” – Dr. Ted Heise
“One of the concerns is the level of burden that is imposed by the expectations wrapped up in this work.” – Dr. Ted Heise
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
*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.
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