The U.S. Food and Drug Administration (FDA) has collected a variety of resources to assist medical device manufacturers in their evaluation of their products for biocompatibility considerations.
Biocompatibility assessment and testing are required for medical devices that come in direct or indirect contact with the human body to determine the potential for an adverse biological reaction to device component materials that could lead to injury or death.
The FDA’s new Biocompatibility Assessment Resource Center provides device manufacturers with a step-by-step approach that addresses: 1) biocompatibility basics; 2) evaluation endpoints; 3) test articles; and 4) test reports. The Resource Center also provides links to additional information regarding each of these steps.
The FDA’s Biocompatibility Resource Center is intended to supplement the FDA’s own guidance on biocompatibility, “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’.” The FDA also welcomes the submission of general questions about biocompatibility issues, which can be emailed to CDRH.Biocomp@fda.hhs.gov.