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1Program Name: ___Date:___CERN Member Name: ___COLLEGE EFFECTIVENESS REVIEW COMMITTEE (CERN) Evaluation Tool for Comprehensive PROGRAM Reviews Purpose: This tool is used to evaluate Comprehensive
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Tool C recommendations are a set of guidelines and best practices for ensuring the safety and effectiveness of medical devices.
Manufacturers, importers, and distributors of medical devices are required to file Tool C recommendations.
Tool C recommendations can be filled out electronically through the FDA's online portal, following the provided instructions.
The purpose of Tool C recommendations is to ensure that medical devices meet regulatory standards and are safe for use by patients.
Tool C recommendations must include details on the design, testing, and clinical evaluation of the medical device.
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