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
Information
Type
Guidance
Regulated products
Biologics, Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket, Safety - Issues, Errors, And Problems
Published
September 8, 2023
Last updated
September 5, 2024
Description
This document provides guidance on the use of ISO 10993-1 for evaluating and testing medical devices within a risk management process.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)