Biocompatibility Requirements for Medical Devices

510(k) submissions for FDA approval

The U.S. Food and Drug Administration (FDA) requires device manufacturers seeking pre-market approval under its 510(k) program to submit testing data verifying the biocompatibility of any device or material that comes in direct or indirect contact with a patient. Yet, according to the FDA, as many as one-third of 510(k) submissions provide inadequate information regarding device biocompatibility, or failed to provide any biocompatibility data at all. For device manufacturers, these shortcomings often result in the rejection of a 510(k) submission or best case, an extended delay in its review by the FDA.

Requirements overview standard compliance

Modern medical devices are comprised of a diverse range of materials and components, each with their own unique physical and chemical characteristics. Although many of these materials present a minimal risk when incorporated into products intended for general use, their inclusion in medical devices significantly expands the scope of potential safety considerations. These can include the leaching of device materials due to heat or wear during normal operation or the migration of chemicals from the device.

In this white paper by UL, we’ll provide an overview of the structure and requirements presented in the latest version of ISO 10993-1 and provide details on the biological safety evaluation process set forth in Annex B of the standard.