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Day 1: Shifting Requirements and Expectations for Chemical Characterization of Medical Devices

Expectations of the FDA regarding the design of chemistry studies in support of medical device toxicology has been shifting rapidly. New expectations have primarily been communicated to laboratories through submission feedback, and pre-submission meetings, as the FDA has not yet released guidance on application of ISO 10993-18. This presentation focuses on how chemistry study design has changed over the last 12 months in response to FDA received from the FDA.

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Duration:	1 hour, 2 minutes
Dates and locations:	Available On Demand Until Aug 25, 2022
Website:	https://event.on24.com/wcc/r/2574415/FCEBCF5720689...

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Nelson Laboratories, LLC

http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

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