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BiocompCHATibility Podcast
FDA and ISO 10993-18: 2020

FDA and ISO 10993-18: 2020

BiocompCHATibility vor 6 Jahren

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27:14

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this bonus episode, our hosts discuss the new FDA
Supplementary Information Sheet (SIS) on ISO 10993-18:2020 and
their extent of recognition. On July 6, 2020 the FDA released
this document to help clarify how manufacturer’s should utilize
ISO 10993-18:2020 for US submissions. With this release, may come
more questions than answers, so we decided to try to clarify this
document and highlight the items that have the most impact to
manufacturers and their upcoming submissions.

“There’s certainly a lot to recognize or not recognize when it
comes to part 18.” – Don Pohl

“What you’re hoping to see there is something that states
complete standard {..} in this instance that is not the case.”
-Don Pohl

“Myself and some of our colleagues were pretty much, if we were
betting people, we were betting this would not be recognized by
the FDA.” – Don Pohl

“Overall, I don’t see these {extent of recognition} as being huge
show stoppers for anyone.” – Don Pohl

Discussion points include:

What is an SIS and how is it helpful

What does partial recognition really mean

How do these changes impact the chemical testing we have
ongoing

What are the 5 main parts not recognized and what does that
mean to manufacturers