An investigational device exemption (IDE) allows the investigational
device to be used in a clinical study in order to collect safety and
effectiveness data required to support market clearance application. An
approved IDE permits the sponsor to conduct clinical trials and use the
data collected in the investigations to support Premarket Approval (PMA)
and Premarket Notification [510(k)] submission.
Service
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Preparing and organizing Pre-IDE meeting
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Organizing and reviewing available material
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Raw materials and products
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Process and control
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Preclinical trial data
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Clinical trial data
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Developing protocols for phase I clinical trial
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Preparing and organizing materials and presentation files for Pre-IDE meeting
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Key opinion leaders (KOL) recruitment
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Correspondence with FDA and holding Pre-IDE meeting
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Rectification according to FDA抯 advices
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Preparing and submitting IDE package
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Preparing and organizing IDE data
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Principal investigator (PI) of clinical trials recruitment
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Selecting clinical trial sites
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IDE drafts review and final versions
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Submitting IDE to FDA as the US agent
Link to "Services" for more information.
