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Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" - PharmaFacts
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Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

Draft Guidance for Industry and Food and Drug Administration Staff

This guidance document is being distributed for comment purposes only.
Document issued on: April 23, 2013


...1. Introduction

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exemptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct or indirect contact with the human body in order to determine the potential toxicity resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." . When final, this guidance will therefore replace ODE General Program Memorandum #G95-1 (1995), entitled Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” This guidance document also incorporates several new considerations, including assessment of known or potentially toxic chemicals (e.g., color additives), and sample preparation for submicron or nanotechnology components, in situ polymerizing and bioabsorbable materials, which were not previously discussed in #G95-1.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe...(see more)