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Recent FDA Biocompatibility Feedback From 510k Submissions

Thor Rollins  (Director, Toxicology and E&L Consulting, Nelson Labs, LLC)

Date: Wednesday, November 4

Time: 1:00pm - 2:00pm

Track: Conference: Digital Health

Vault Recording: TBD

Submitting for an approval for a medical device through the FDA can be a stressful and anxious time. It is important to understand the most recent recommendations from the agency. Too often these recommendations are given through feedback from the submission process itself, making a proactive approach difficult. In this presentation we will review recent FDA suggestions from real 510k submissions. These suggestions will touch on all aspects of the ISO 10993 standard series from cytotoxicity, sample preparation, E&L, toxicology, and more.

From this presentation, audience members will learn:

• Which biocompatibility topics is the FDA most focused on?
• What points are important to include in our extractable and leachable testing?
• How should you set up your sample preparation?
• What concerns to address in your biocompatibility testing before you start the tests?



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