MIND THE GAP between ISO 10993 and submission to FDA

by Chiara Picotti, Eurofins BioPharma Product Testing, ChiaraPicotti@eurofins.com

ISO 10993 series regarding the biological evaluation of medical devices is considered the "gold standard" for biocompatibility issues. A new draft guidance to assist industry with ISO 10993-1 was issued by FDA in April 2013: Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." This guidance is intended to replace the historical "Blue Book Memorandum #G95-1" (1995) and to address new topics regarding new materials such as nanotechnology and bioabsorbable materials.

The FDA focuses also on subjects like the test selection, considering not only the nature, degree, frequency and duration of body exposure, but also the chemical characteristics of device materials (including colour additives), eventual target population and target organs. FDA encourages manufacturers to discuss their testing plans with them and affirms that safety studies performed in a relevant animal model, designed to include peculiar endpoint, may justify omission of some biocompatibility tests.

Another topic covers the samples to be tested: they should be the final products or representative coupon devices; the favourite extraction ratio is the surface/ volume ratio. GLP (Good Laboratory Practices) accreditation is a must for biocompatibility reports, which should contain a well-defined test method and parameters, acceptance criteria and analysis of results. Finally, there are some new specific considerations on several tests e.g. cytotoxicity, sensitisation, pyrogenicity, implantation, genotoxicity, carcinogenicity and reproductive toxicity.

Even if this guidance hasn't been formally released, it gives clear understanding of FDA's thinking regarding biocompatibility.

Since the early '90s, Eurofins scientists have successfully performed biocompatibility testing and have the technical expertise required by the ISO 10993 and FDA guideline standard series, including in vitro and in vivo testing. During the last several decades, Eurofins has had the opportunity to participate in very interesting projects involving different kind of devices where the studies have been used for regulatory registration in many countries worldwide (CE mark in Europe, FDA submissions, Japan, Korea, China, etc.). And Eurofins' experts are currently participating in the international ISO groups in charge of the development of the ISO 10993 standards, continually staying updated on normative news and changes.

For more information on how Eurofins can help you reach FDA submission, visit www.eurofins.com/pharma-services