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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact ASTM International (www.astm.org) for the latest informationDesignation: F3168 20Standard Practice
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ASTM F3168-23 is a standard developed by ASTM International that provides guidelines and requirements for the construction and performance of medical devices.
Manufacturers of medical devices that are seeking compliance with industry standards and regulatory requirements are required to file under ASTM F3168-23.
To fill out ASTM F3168-23, manufacturers should review the standard's guidelines, complete the necessary documentation specifying compliance with the outlined requirements, and submit any additional data requested.
The purpose of ASTM F3168-23 is to ensure the safety, effectiveness, and quality of medical devices through standardized criteria.
The information that must be reported includes device specifications, compliance with testing requirements, performance data, and labeling information.
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