Toxicological Risk Assessment

The Toxicological Risk Assessment (TRA) is an important tool in the safety assessment of biomedical devices, providing a chemical-based approach which complements a traditional animal-based testing program. The need for TRA is growing and may be considered as a means of circumventing animal testing in the safety evaluation of devices.

Understanding Risk Assessment

The pathway to regulatory approval for medical products can be lengthy and expensive. Based on the FDA Biocompatibility Guidelines, it is essential to conduct your safety testing within a risk management context; this may be advantageous in reducing your time-to-market without compromising on safety. The right consulting partner can help you evaluate options and develop approaches that meet regulatory requirements efficiently and effectively.

ToxSmart™, Toxikon’s risk assessment consulting group, provides sponsors with dedicated resources to develop cost-effective, strategic approaches to safety and efficacy testing that will help you achieve regulatory compliance for medical devices and drug products. Our team of toxicologists, chemists, and regulatory experts will collaborate with you to ensure that the biological safety evaluation is carried out in a risk management context, mitigate risk (if applicable), and accelerate the regulatory approval process.

Service Offerings

  • Toxicological Risk Assessment
  • Gap Analysis
  • Regulatory Strategy
  • Raw Material Safety Investigation
  • 510(k) Submission Support
  • Study Design for:
  • Biocompatibility Testing
  • Chemical Characterization
  • Extractables & Leachables

Regulatory Guidance

  • ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process
  • ISO 10993-17: Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances
  • ICH Q3D. 2015: Elemental Impurities: Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
  • ICH M7. 2015: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry
  • ISO 14971, 2007: International Standard. Medical Devices- Application of Risk Management to Medical Devices. Second Edition. Reference Number ISO 14791:2007(E)
  • ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications

Toxikon’s Expertise in Risk Assessment Consulting

ToxSmart utilizes publicly-accessible research tools on the internet, including search engines and on-line toxicology databases. Computer-aided programs in quantitative structure-activity relationships (QSAR) are also utilized as needed and Toxikon uses the CASE Ultra program (MultiCase, Inc., Beachwood, OH) and other publicly-accessible programs, including ToxTree™ and the OECD Toolbox.