What is the FDA looking for in your Extractable and Leachable (E&L) Testing study? How do ISO 10993-18 and FDA expectations overlap and differentiate? Watch now to learn how to correctly run your E&L study according to FDA requirements.
The data gained from these studies can help understand the total risk of your device to an intended population of users; but unlike the traditional animal tests, it comes with separate risks.
These tests are not your typical “stamped” tests, where every lab gives a similar quality of results. Because of this, FDA has refined a strict, detailed, list of parameters that should be included in every test. This list is very dynamic and is changing rapidly.
This presentation by Matthew Jorgensen, Chemist, Materials Scientist, and Toxicologist at Nelson Labs and his colleague, Thor Rollins, Director of Toxicology, examines the most recent FDA feedback on E&L studies and how you can use it to address common concerns and develop a protocol.
In this video you'll also learn how to conduct toxicological evaluation and replace traditional tests like systemic toxicity, genotoxicity, reproductive toxicity, and carcinogenicity.
★ KEY VIDEO TAKEAWAY★
- The chemistry for toxicology (ChemTox) process is often viewed as a requirement for medical device studies, if you only do animal studies, you can get kick-back from regulatory bodies asking for chemical information.
This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks:
1) GO Track - Covering everything you need to know to get new devices to market with less risk
2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market
3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic
The video you’re watching now is from our GROW Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event: • The Greenlight Guru Tr...
Plus, download the slides from this presentation for free here:www.slideshare.net/greenlight...
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