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Submission of Exemption RequestCALIFORNIA FORM3500AExemption Based on Internal Revenue Code (IRC) Sections 501(c)(3), 501(c)(4), 501(c)(5),
501(c)(6), 501(c)(7), or 501(c)(19), Federal Determination
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What is form 3500a submission of?
Form 3500a submission is for reporting adverse events or product problems with medical devices to the FDA.
Who is required to file form 3500a submission of?
Manufacturers, importers, and user facilities of medical devices are required to file form 3500a submission.
How to fill out form 3500a submission of?
Form 3500a submission can be filled out electronically through the FDA's MedWatch Online Voluntary Reporting Form.
What is the purpose of form 3500a submission of?
The purpose of form 3500a submission is to provide the FDA with important information about adverse events or product problems with medical devices.
What information must be reported on form 3500a submission of?
Information such as the device model, manufacturer, description of the adverse event, date of occurrence, and any patient outcomes must be reported on form 3500a submission.
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