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 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

To ensure patient safety, all medical devices that contact the human body undergo biocompatibility safety assessments prior to market release. These include the biological and toxicological safety assessment of the broad spectrum of medical devices currently on the market and emergent technologies (for example, novel materials).

Through research and contributions to international standards organizations, the FDA has evaluated and refined testing methods to help harmonize approaches for biocompatibility evaluation for regulatory review of medical devices to further consistency in regulatory decisions. In addition, the FDA conducts consults in biocompatibility, chemical characterization, and toxicological risk assessments, which have increased by 40% in the last two years to a total of approximately 800 per year.

To address emergent and persistently reported postmarket medical device safety signals or problems, it is critically important that we address gaps in our knowledge and ability to accurately assess the biological and toxicological responses relevant to safety of medical device implants.

Regulatory Science Gaps and Challenges

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

• Emergent and recurrent medical device postmarket signals that reveal gaps in the knowledge and ability to accurately assess the safety of medical devices.
• Chemical characterization approaches that are not yet standardized resulting in inconsistencies between testing laboratories, which raises questions of accuracy and reliability
• Lack of tools that are needed to reduce long and costly biological testing and respond to trends and priorities to improve the predictivity of product safety.

The Biocompatibility and Toxicology Program is intended to fill these knowledge gaps by improving and advancing safety assessment approaches that are least burdensome to the medical device industry without compromising patient safety.

Biocompatibility and Toxicology Program Activities

The Biocompatibility and Toxicology Program focuses on regulatory science research in these areas:

• Novel or updated alternative approaches (for example, in vitro cell tests) to traditional tests for evaluating biocompatibility of implants and other medical devices that are associated with improved predictivity of clinical responses as well as low incidences of false negatives.
• Chemical characterization methods for extractables and leachables (E&L) testing to reliably detect, identify, and quantify chemicals of potential concern medical device extracts that may leach from devices during clinical use to improve toxicological risk assessments.
• Predictive computational toxicology approaches and databases to address specific toxicological issues that could reduce reliance on biological testing of medical devices.

For more information, email [email protected]