FDA is incorporating a risk-based approach for analyzing biocompatibility of medical devices that come into direct or indirect contact with the body.
The FDA’s final guidance provides specifics on how to conduct a biocompatibility assessment using the International Organization for Standardization (ISO)-10993. The document updates April 2013 guidance.
When assessing new devices, the sponsor should state if the device has direct or indirect tissue contact to determine if further biocompatibility testing is needed.
Similarly, when assessing device modifications, the sponsor should clarify if a modification results in a change to direct or indirect tissue contact. If a modification would result in direct or indirect contact, a biocompatibility evaluation should be conducted.
The document addresses how to evaluate sterile and non-sterile medical devices that come into contact with the body, including:
The final guidance provides specific information to include in: