March 28, 2019
Recently, FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren released comments summarizing FDA's past and future efforts to evaluate safety concerns related to the materials from which implanted medical devices are constructed. While FDA acknowledges that the vast majority of implanted devices have no adverse reactions, FDA has called attention to what it believes is a growing body of evidence suggesting that a small number of patients may have a predisposition toward biological/immune/inflammatory responses to certain types of implanted materials. In these cases, symptoms may not arise for several years following implantation.
"FDA has been carefully evaluating the body of evidence on this issue. This includes current published studies, information submitted to us in reports in our public adverse event database or through data from post-market studies that we required manufacturers to conduct. We also have our own teams of FDA scientists and engineers conducting research to better understand device materials…" said the FDA statement. "Enhancing our collective understanding of materials science could lead to identifying materials that may cause exaggerated response in sensitive individuals and advance the development of safer materials. Development of new tests to identify at-risk patients would help ensure they do not receive implantable devices that contain material to which they are sensitive, therefore enhancing patient safety and advance a precision medicine approach to the selection of device interventions."
FDA seeks to engage the public, scientists, and industry stakeholders to gather information and determine the current state of science, as well as identify any gaps that need to be addressed. FDA announced several upcoming public meetings in 2019 and the upcoming publication of a white-paper and guidance on these issues.
Based on the scope of this announcement, we anticipate that specific areas of focus may include device biocompatibility, leachable/extractable testing, epidemiology, and toxicology as well as novel materials characterization methods. Particular scrutiny will be given to the following medical device categories: silicone breast implants, metal devices — particularly those made from nitinol (a super-elastic alloy), hip replacement devices, materials sourced from animal origins, and innovative materials (e.g., nanotechnology).
How Exponent Can Help
FDA's targeted announcement suggests the application of higher levels of regulatory scrutiny to the evaluation of implant materials. Key to navigating this new landscape will be cutting-edge materials science, toxicology risk assessments, health outcomes, and regulatory science expertise. Exponent has a depth and breadth of knowledge in these areas and has provided clients with innovative solutions for pre-market and post market solutions. These have included:
- Pre- and post-market device performance and safety testing.
- Development of methods to characterize biomaterials, including metals, polymers, tissue-derived materials as well as novel biomaterials.
- Toxicological and biocompatibility evaluations of medical device materials to support FDA application submissions.
- Assessment of extractable and leachable substances from biomaterials according to ISO 10993 to support FDA application submissions.
- Identification of new/modern technology standards for device evaluation.
- Evaluation of candidate objective safety and performance criteria for use with innovative technologies.
- Assistance with identifying the appropriate regulatory strategy for new or modified biomaterials and new technologies.
- Identification and analysis of real-world data to understand device performance and safety, and to support regulatory submission and post-market surveillance strategies.
- Analysis and interpretation of clinical data and real-world data on predicate devices, including data from registries.
- Technical support for regulatory submissions and compliance
- Failure analysis as part of complaint or recall investigations