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Currently medical device irritation testing is conducted using a rabbit skin irritation test, while sensitization is evaluated primarily by the guinea pig maximization test. This presentation will briefly review these two animal methods, present the current status of in vitro alternatives, and provide an update on the ISO 10993-10 and ISO 10993-23 standards.
Additive manufacture, also known as 3-D printing, has a huge potential in the development and production of small scale or personalised medical devices. The technology is gaining acceptance in the production of surgical planning models and medical device prototyping. There are however presently very few 3-D printed medical devices which contact the body approved for market. One of the areas of concern for such devices is how to assess the biological safety of the device and the additional risks introduced by the materials and printing process. I will discuss recent guidance provided by US FDA and other regulatory bodies and also present a case study of how an authority’s concerns over biological safety were addressed when seeking clinical trial approval for a 3-D printed device.