April 6, 2020
The following virtual presentation was originally planned for SOT Annual Meeting, which was cancelled. All registrations for the virtual meeting go through SOT.
Event Information: SOT Webinar: Medical Device Safety Assessments: Challenges & Approaches for Handling Chemical, Hazard & Regulatory Uncertainty
Thursday, April 16, 2020 1:00 pm
Eastern Daylight Time
Chair(s): Tom Lewandowski, Gradient; and Alan Hood, US FDA/CDRH.
The regulatory landscape for the safety evaluation, clinical testing, and commercial development of medical devices is undergoing considerable changes, including new requirements for material characterization and chemical risk assessment early on in the development process. In this dynamic environment, extractables/leachables (E/L) analysis is becoming a key tool in biocompatibility assessments to ensure patient safety and establish regulatory compliance. The first speaker will begin the discussion on medical device chemical characterization strategies, a necessary step for understanding potential chemical exposures from medical device components. The presentation will include examples of how information concerning material chemistry and the manufacturing process can reduce the cost and effort associated in resolving “unknown” extractable compounds. The next presentation will focus on predictive toxicology methods (e.g., computational toxicology programs, read-across, Threshold of Toxicological Concern) for evaluating potential risks from extractable compounds. Case studies will be presented to demonstrate the importance of expert judgment when interpreting in silico hazard predictions, as well as approaches for justifying a read-across approach for risk assessment of extractable compounds. The third speaker will then discuss the US Food and Drug Administration (US FDA) perspective on the issues raised in the preceeding talks. Agency experience with unique nontargeted analytical methods that generate data adequate for toxicological risk assessment will be presented, which include, but are not limited to, extraction method design, analytical instrument/tool selection, selecting an analytical evaluation threshold (AET), sample manipulation, system suitability, calibration, identification/semi-qualification, and data reporting. The final speaker will present a broader overview of the global regulatory landscape for medical device safety evaluation. Notable activity includes the revision of ISO 10993-1, implementation of the European Union’s revised Medical Devices Regulation, and amendments to California Proposition 65. This presentation will cover how new requirements for extractables/leachables analysis will affect the manufacturer’s ability to justify the safety of hazardous substances within devices, verify warning label exemption, evaluate biological equivalence of predicate/proposed devices, and support supply chain controls and ensure efficient change management.
Introduction. Tom Lewandowski, Gradient, Seattle, WA.
Chemical Characterization Strategies for Medical Device Biocompatibility Assessment. Adam Kozak, Cambridge Polymer Group Inc., Boston, MA.
Predictive Toxicology Approaches for Medical Device Biocompatibility Assessment. Joel Cohen, Gradient, Cambridge, MA.
CDRH Scientific Perspective on Material Characterization and Toxicological Risk Assessment of Nontargeted Medical Device Extractables. Berk Oktem, US FDA/CDRH, Silver Spring, MD.
Extractables and Leachables Analysis of Medical Devices in a Changing Global Regulatory Environment. Whitney Christian, Medtronic, Jacksonville, FL.
Registration is required.