FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.
Some new topics of the draft include biocompatibility considerations for new types of materials such as nanotechnology and bioabsorbable materials. Also, there is a fairly extensive section on color additives, which may be potentially toxic, and how you should handle color additives in your products.
The draft is pretty detailed, hitting on topics ranging from sample preparation, to animal welfare, to going into specifics of the testing considerations of different tests (genotoxicity, implantation, cytotoxicity, etc.) It also outlines what exactly should be included in your biocompatibility reports, and offers example documentation language or “canned text” that you can use as part of your documentation and rationale for biocompatibility.
There is an updated test matrix in the appendix that lists all of the tests recommended by FDA. Throughout the document, it reiterates that the testing recommendations in 10993-1:2009 may not be enough to satisfy some biocompatibility concerns that the FDA has for certain contact types/durations. Comparing the FDA’s Matrix with the ISO 10993-1:2009 Matrix side by side, you will see a few more x’s on the FDA’s side.
The release of this draft guidance document is good news for the industry as it can help us understand FDA’s position and concerns related to biocompatibility. Many of our clients have seen FDA’s focus on biocompatibility first hand in questions they’ve received on premarket submissions. The comment period on the draft guidance stretches until July, so if there is anything that ‘irritates’ you (pun intended), voice your opinion.
This is definitely worth a read! Click the link below for the full document.