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FDA Presubmission Program: Study Risk Determinations Introduction FDA will help sponsors, clinical investigators, or institutional review boards (IRB) make a study risk determination. FDA will provide
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What is fda pre-submission program?
The FDA pre-submission program allows medical device manufacturers to get feedback from the FDA before formally submitting their application for approval.
Who is required to file fda pre-submission program?
Medical device manufacturers who are looking to seek FDA approval for their devices are required to file the pre-submission program.
How to fill out fda pre-submission program?
To fill out the FDA pre-submission program, manufacturers must submit a detailed summary of their device, proposed testing plans, and any other relevant information requested by the FDA.
What is the purpose of fda pre-submission program?
The purpose of the FDA pre-submission program is to provide manufacturers with valuable feedback from the FDA early in the device development process, helping to streamline the approval process.
What information must be reported on fda pre-submission program?
The FDA pre-submission program requires manufacturers to report detailed information about their device, proposed testing plans, and any other relevant information requested by the FDA.
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