The Biocompatibility and Toxicology Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research on the interactions between medical devices and the human body to help ensure patient access to innovative devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Biocompatibility, Toxicology, and Medical Devices

All medical devices that contact the human body undergo biocompatibility safety assessments prior to market release. Pre-clinical research undertaken to address pre-market questions raised about the biocompatibility of medical devices is multidisciplinary and encompasses the use of biological evaluation and toxicological risk assessment technologies including novel in vitro, ex vivo/in vivo testing, and computational/in silico methodologies.

The Biocompatibility and Toxicology Program (BTP) addresses the biological and toxicological safety of the broad spectrum of medical devices currently on the market and emergent technologies (such as novel materials). The regulatory science efforts of the BTP are cross-cutting and span multiple medical device product lines to support the regulatory activities across all OPEQ offices. Specifically, the scope of this program is focused on promoting the acceptance/qualification of methods/tools (such as New Approach Methodologies [NAMs]*) or development of international standards or guidance for:

• evaluating biocompatibility (i.e., biological) endpoints and
• evaluating/estimating toxicological risk.

* Note: NAMs include a broad range of "alternative methods" such as in vitro, in chemico, in silico (such as, computational, bioinformatics), and systems biology approaches. In vivo methods can also be considered NAMs when they improve predictivity, shift studies to phylogenetically lower animals, or help replace, reduce, and refine animal use (that is, the 3Rs).

Regulatory Science Gaps and Challenges

The major regulatory science gaps and challenges that drive the Biocompatibility and Toxicology Program are:

• Insufficient New Alternative Methodologies (NAMs) validated/qualified for biocompatibility assessment of medical devices.
• A need for tools/methods (such as web-based/computational, guide) that facilitate and improve consistency of toxicological risk assessments for medical devices.
• Inadequate guidelines for evaluating biocompatibility of medical devices throughout their device lifetime.

Through regulatory science research, the Biocompatibility and Toxicology Program seeks to fill these knowledge gaps in order to improve and advance safety assessment approaches that are least burdensome to the medical device industry without compromising patient safety. To achieve this goal, the Biocompatibility and Toxicology Program evaluates new, as well as refines current, testing approaches to help harmonize methods for biocompatibility evaluation of medical devices and promote further consistency in the regulatory review of pre-market submissions.

Biocompatibility and Toxicology Program Activities

Currently, the Biocompatibility and Toxicology Program focuses on regulatory science research in the following areas:

• Evaluating the performance of in vitro test methods (such as reconstructed human epidermis [RhE] irritation test) with the objective to support their regulatory acceptance for assessing the biological risk(s) of medical devices.
• Establishing toxicological risk assessment tools (such as based on ISO 10993-17) to standardize calculations and promote uniformity in the toxicological risk assessment of medical devices.

For more information, email OSEL_biocomptox@fda.hhs.gov