Biocompatibility Testing of Combination Products & Medical Devices: New Regulatory Guidance
Navigating the technical and regulatory pathways for combination products is challenging enough when considering the complex requirements dictated by both the pharmaceutical and medical device components. The challenge increases when facing the subtle nuances imposed by regulators when filing in multiple international markets. FDA’s guidance document on ISO 10993-1, issued in June 2016, provides additional considerations for biocompatibility testing that pharmaceutical companies should be mindful of as they develop their combination products.
Join this informative webinar to learn how to implement an efficient testing program for assessing the biocompatibility of a combination product’s device component, which incorporates the relevant requirements of ISO 10993-1, to satisfy both US and international regulatory agencies.
This presentation will include real-world case studies and best practices for:
- Chemical characterization, including extractables and leachables testing
- Toxicological risk assessments
- Biocompatibility testing
- Pitfalls to avoid while developing testing plans
- Future trends for combination products
- Implications of new FDA guidance on the use of ISO 10993-1