FDA issued the final guidance on biocompatibility, UCM348890. Entitled Use Of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, it replaces Blue Book Memorandum #G95-1 (1995), Use Of International Standard ISO 10993, Biological Evaluation Of Medical Devices – Part 1: Evaluation And Testing.
The guidance assists industry in PMAs, HDEs, IDEs, 510(k)s, and de novo submissions for medical devices that come into direct or indirect contact with the human body to determine the potential for an unacceptable adverse biological response.
The guidance is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body and covers the following topics:
- Use of risk assessments for biocompatibility evaluations for a proposed medical device
- Use of ISO 10993-1:2009 and the FDA-modified matrix to determine the relevant biocompatibility endpoints for an evaluation
- General biocompatibility testing considerations, including test article preparation
- Specific considerations for cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments
- Chemical assessment recommendations; and considerations for labeling devices as “-free”