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.

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.

Toxicological Risk Assessment of E&L Compounds

Systematic Review and Evaluation of Toxicity Data

Computational Toxicology

Exposure Assessment

Risk Characterization

Providing assistance to clients submitting applications to qualify NAMs for regulatory use under the FDA/CDRH Medical Device Development Tools (MDDT) program.

Analysis of the need to account for account for bioaccumulation in biocompatibility testing

Refining methods to conduct in vitro - to - in vivo extrapolation (IVIVE) of dose for device related compounds

Validating QSAR models to predict the skin sensitization potential of device related E&L compounds

Development of clear, authoritative white papers, best practice documents, and regulatory reports addressing emerging risk assessment and compliance challenges. Our work helps to combines research with practical insight to translate complex regulatory and scientific issues into actionable guidance aligned with current and evolving regulatory expectations.