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 a final guidance entitled "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process'." This guidance was revised to incorporate updates to FDA's current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. 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 premarket approval applications (PMAs), humanitarian device exemptions (HDEs), investigational device exemption (IDE) applications, premarket notifications (510(k)s), and De Novo requests.