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Recent FDA feedback regarding extractable and leachable testing and how to make sure FDA will accept your testing protocol

June 23, 2020

One of the newest biocompatibility evaluations tools is extractable and leachable (E&L) testing.  A correctly run E&L study, with an accompanying toxicological evaluation, can be used to replace traditional tests like systemic toxicity, genotoxicity, reproductive toxicity, and carcinogenicity. 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; the best way to make sure you are performing the correct version of the test is to learn from the most recent FDA feedback on studies.

Key points in this webinar:

  • Understand recent FDA feedback and dissect what FDA is asking/looking for.
  • Learn how to address these concerns and develop a protocol to make sure you don’t receive similar questions.
  • Recognize how FDA is using the new ISO 10993-18 and where they deviate from that standard.