Shifting Requirements Within the FDA: Expectations in Chemistry Study Design

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.

Attendees will learn:

• Expected sensitivity of analysis, the analytical evaluation threshold (AET), and appropriate inputs in AET derivation
• Exhaustive extractions, comparison of NVR to analytical results
• Expectations for evidence of method suitability, standards and calibrations