Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process”; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process.' " FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response 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- 1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process" to support applications to FDA. This guidance supersedes Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled "Use of International Standard ISO-10993, `Biological Evalua