FDA publishes new dataset to aid medical device biocompatibility testing

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in medical devices. The agency says the dataset is meant to help streamline the medical device biocompatibility testing and review processes.

The dataset, called the Chemicals List for Analytical Performance (CLAP), includes 100 example chemicals characterized by the Center for Devices and Radiological Health’s (CDRH) laboratories. It includes the physicochemical properties of the chemicals and is meant to help medical device sponsors determine whether the chemicals they use in their device development are biocompatible.

“This dataset will allow analytical chemistry labs to determine their ability to detect a broad range of potential chemicals,” said CDRH Director Jeff Shuren. “The example chemicals can be assessed by laboratories using their own [gas chromatography (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,” he added. “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).”

Biocompatibility has been an important topic for CDRH as the agency has held public meetings on the topic and published several guidances. At the start of the year the agency proposed an orthopedic products guidance, which would require data on metallic or calcium phosphate substances used for coating the products, the coating process, sterility considerations, and biocompatibility considerations. (RELATED: FDA proposes guidance on orthopedic product coatings, Regulatory Focus 22 January 2024)

“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,” said Shuren.

Shuren also noted that FDA issued the first version of its biocompatibility guidance in 2016, which is based on the international consensus standard ISO 10993 Part 1 and takes a risk-based approach. That guidance was updated for a second time in September and now includes a list of polymers and fabrics that may be exempt from biocompatibility testing and other requirements. (RELATED: FDA updates medical device biocompatibility guidance with exclusion list, Regulatory Focus 12 September 2023)

“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,” said Shuren. “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.”

Shuren added that the non-animal-based analytical chemistry surrogate test can be used by sponsors to understand the effects of certain chemicals that may leach from their device. Ultimately, he said the new dataset is meant to provide more transparency and efficiency to the medical device development and review process.

CLAP dataset, FDA statement

FDA publishes new dataset to aid medical device biocompatibility testing

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