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…
