FOR IMMEDIATE RELEASE
April 16, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories (OSEL), CDRH

Today, the FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

This dataset will allow analytical chemistry labs to determine their ability to detect a broad range of potential chemicals. Provided are links to the first set of chemicals along with their physicochemical properties, as well as the CDRH provided results when using gas chromatography (GC) protocols.

The example chemicals can be assessed by laboratories using their own GC protocols to determine whether the chemicals are detectable compared with one of the specific chemicals in the dataset measured by the relative response factor (RRF). If detectability is shown to be similar to the RRFs obtained by CDRH, there can be an increased confidence in the protocols being used by the lab. In the future, CDRH intends to increase the breadth of the dataset of chemicals and RRF information it makes publicly available, and to add other detection methodologies such as liquid chromatography (LC).

This new dataset is part of CDRH’s ongoing commitment to help reduce the burden of premarket processes, while increasing the consistency and transparency of biocompatibility assessment methods.

In 2016, CDRH issued the first version of FDA’s Biocompatibility Guidance based on the international consensus standard ISO 10993 Part 1, which outlines the Center’s approach to the biocompatibility evaluation of medical devices within a risk management process. A central tenet of the CDRH biocompatibility evaluation is for sponsors to have the option, for some biocompatibility endpoints, to undertake extraction studies to identify and quantify chemicals released from a device and then to perform a toxicological risk assessment (TRA) to determine if the chemicals pose safety issues in the use of the device.

A successful TRA determination is dependent on the sensitivity of the analytical chemistry method used to detect and quantify chemicals that may be present following extraction from a medical device. This non-animal-based analytical chemistry testing approach is used as a surrogate to predict the exposure of chemicals that may be released by medical devices in use.

Through this new approach and other actions, CRDH will continue working to make the premarket review process as efficient and seamless as possible for developers and other stakeholders, while enhancing transparency around biocompatibility assessment and prioritizing safety for all devices undergoing the premarket review process.

Additional Resources

• Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology
• Materials and Chemical Characterization Program: Research on the Materials and Chemical Characterization of Medical Devices