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BiocompCHATibility
A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.
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 manufacturers should utilize ISO 10993-18:2020 for U.S. regulatory submissions. However, with this release may come more questions than answers, so we decided to try to clarify this document and highlight items that have the most impact on manufacturers and their upcoming FDA 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
“If we were betting people, we were betting this {table} 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 ongoing chemical testing?
- What are the 5 main parts not recognized and what does this mean for manufacturers?
Also be sure to check out our Biocompatibility Strategy Navigator.