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Massachusetts Department of Higher Education Massachusetts Department of Elementary and Secondary EducationInnovation Pathways Preliminary Designation Application 7.31.17Table of ContentsOverview
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Innovation pathways preliminary designation is a step taken by companies to seek regulatory guidance from the FDA for their innovative medical devices.
Companies developing innovative medical devices are required to file innovation pathways preliminary designation.
To fill out innovation pathways preliminary designation, companies need to provide information about their device, proposed indication, and regulatory strategy.
The purpose of innovation pathways preliminary designation is to streamline the regulatory process for innovative medical devices and facilitate communication between companies and the FDA.
Information such as device description, indication, intended population, and regulatory strategy must be reported on innovation pathways preliminary designation.
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