Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)
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Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)

August 28, 2017

Presented at the 2017 World CongressĀ on Alternatives and Animals in the Life Sciences (WC10)

E. Hill, R. Curren, and G.-E. Costin

Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach to substitute for the RVI. Our Validation Program will analyze paired in vivoin vitro data for vaginal irritation utilizing commercially available human reconstructed vaginal tissue models. A Prediction Model will be proposed that can be used for the safety assessment of personal lubricants. Our Validation Program proposal has been accepted in the Incubator Phase of the US FDA Medical Device Development Tool (MDDT) Pilot Program and is currently ongoing.