FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation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.
I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.
I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.