The draft version of the Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was already available in 2013.
The FDA now published the final version of the successor of the famous "Blue Book Memorandum #G95-1" which is now one of the major documents to be considered for a 510(k), PMA, HDE or IDE.
It now introduces:
- ·use of risk assessments for biocompatibility evaluations for a proposed medical device;
- ·use of ISO 10993-1 and the FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints for an evaluation;
- general biocompatibility testing considerations, including test article preparation;
- specific considerations for the following testing: cytotoxicity, sensitization, hemocompatibility, pyrogenicity, implantation, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and degradation assessments;
- chemical assessment recommendations;
- and considerations for labeling devices as “-free.”
Special attention should be paid to:
- Attachment B that identifies the minimum set of information to support biocompatibility evaluation
- Attachment C including an example of the Summary biocompatibility documentation
The 68 pages guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: valuation
and testing within a risk management process" is available on the FDA Website.