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

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

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023
Language(s):
English
Format:
Text
Subject(s):
Biological evaluation of medical devices
Device Approval
Equipment and Supplies -- adverse effects
Government Regulation
Guidelines as Topic
United States
Genre(s):
Guideline
Technical Report
Abstract:
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications, 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 document also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (66 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918716788306676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918716788306676