Area of Expertise
1. Toxicological Risk Assessment of Extractables and Leachables Released from Medical Devices
- Derivation of Tolerable Intake (TI) values for E&L compounds,
- Use of computational methods (QSAR, Read Across) to predict the toxicity of E&L compounds in the absence of compound-specific toxicity data, and
- Use of toxicological risk assessment and biocompatibility data to establish toxicological equivalence between predicate and new devices.
2. Development of Strategies for the Biological Safety Evaluation of Medical Devices
- Development of least burdensome approaches to evaluate biocompatibility,
- Use of the chemical characterization/risk assessment approach as an alternative to animal-based biocompatibility testing,
- Leveraging existing biocompatibility data for the safety assessment of devices with a formulation change or processing change, and
- Assisting clients in addressing biocompatibility issues identified in FDA deficiency letters.
3. Training in Toxicological Risk Assessment
Courses offered in:
- Toxicological Risk Assessment of E&L Compounds
- Systematic Review and Evaluation of Toxicity Data
- Computational Toxicology
- Exposure Assessment
- Risk Characterization
4. Development, Validation, and Qualification of New Approach Methodologies (NAMs)
- Providing assistance to clients submitting applications to qualify NAMs for regulatory use under the FDA/CDRH Medical Device Development Tools (MDDT) program.
5. Research to Develop New Toxicological Risk Assessment Approaches
Research projects are underway to:
- Determining the appropriateness of existing Cramer Class values for E&L compounds released from devices,
- Developing internal TTC values and inhalation TTC values for device-related E&L compounds, and
- Validating QSAR models to predict the skin sensitization potential of device-related E&L compounds.
