FDA’s new guidance for biocompatibility assessment of medical devices raises the testing bar

Andrew Blakinger, Manager, Extractables, Leachables, & Chemical Characterization Testing, Biocompatibility Testing, & Toxicology Services, Eurofins Medical Device Testing

Biocompatibility is defined as the ability of a material to perform in a specific application without causing an adverse reaction in the body. For medical devices, biocompatibility is assessed using the ISO 10993 series of standards.

This biocompatibility assessment starts with a Biological Evaluation Plan (BEP) and ends with a Biological Evaluation Report (BER). The BEP identifies the medical device’s biological hazards and associated risks. It also outlines the biological endpoints (e.g., cytotoxicity, irritation, systemic toxicity, etc.) that should be evaluated based on the identified risks. Ultimately, the BER summarizes the results of the testing, including a conclusion regarding the device’s biocompatibility.

In between the BEP and BER is when testing occurs. Chemical characterization testing per ISO 10993-18 is performed to identify the chemical constituents and extractables and leachables. Then, a toxicologist assesses this chemical data in a toxicological risk assessment (TRA) per ISO 10993-17. The chemical data and TRA are critical because they can reduce the required biological testing. Finally, various in vivo and in vitro biological assays (described in other sections of ISO 10993) are performed.

In recent years, there’s been significant development in regulatory expectations regarding biocompatibility assessments. There have been many revisions to the ISO 10993 series of standards, and the FDA has drafted numerous guidance documents on the topic. As recently as September 2024, the FDA published a draft guidance on the Chemical Analysis for Biocompatibility Assessment of Medical Devices, which outlines expectations and significantly raises the bar for performing chemical characterization testing per ISO 10993-18.

At Eurofins Medical Device Testing, we partner with our clients to serve as their one-stop-shop for establishing the biocompatibility of medical devices. In North America, our lab facility in Lancaster, PA, serves as our center of excellence for chemical characterization testing and toxicology services, while our site in Dayton, NJ, is the center of excellence for the in vivo and in vitro biological assays. Our skilled toxicologists and biocompatibility experts can also draft clients’ BEPs and BERs. Our team in Lancaster will serve as the single point of contact while coordinating all required testing. Most importantly, our scientists ensure all testing and aspects of the biocompatibility evaluation are performed in accordance with current regulatory requirements.