Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing”; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.' " 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 the Office of Device Evaluation (ODE) General Program Memorandum G95-1 entitled "Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,' " dated May 1, 1995. When final, this guidance will therefore replace G95-1. This draft guidance is not final nor is it in effect at this time.