The U.S. Food and Drug Administration (FDA) has issued a final guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body.
ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, is intended to determine the extent to which direct or indirect contact with a medical device has the potential to induce an unacceptable biological response on the part of the patient. The standard is an FDA-recognized consensus standard and can be used to demonstrate compliance with the FDA’s safety requirements in premarket applications (PMAs), humanitarian device exceptions (HDEs), and investigational device applications (IDAs) submitted to the agency.
According to the FDA, the final guidance provides further clarification and updated information on the use of the standard. The guidance also incorporates several new considerations, including the use of risk-based approaches in assessing biocompatibility in devices and components.