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