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Nova Southeastern University
One of Clinical Research
3300 S. University Drive
Fort Lauderdale, FL, 333282004Protocol Approval Record
For Federally Funded Human Subject ResearchINSTRUCTIONS
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Individuals who are considering purchasing the device and want to test its effectiveness before making a decision.
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What is trial of device that?
Trial of device that refers to a legal proceeding or process where the functionality, efficacy, or safety of a specific device is tested in a controlled environment to gather evidence for regulatory review or litigation.
Who is required to file trial of device that?
Manufacturers, researchers, or any entity involved in developing or testing the device are typically required to file a trial of device that with the appropriate regulatory body.
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To fill out the trial of device that, one must complete the specific application or form provided by the regulatory authority, detailing the device specifications, trial protocol, and any preliminary data supporting the trial.
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The purpose of trial of device that is to assess the safety and effectiveness of the device before it can be approved for public use or marketed.
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Information that must be reported includes device description, study objectives, methodology, subject eligibility criteria, outcomes, and data supporting safety and efficacy.
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