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SMG h:2205.1 FDA STAFF MANUAL GUIDES, VOLUME III GENERAL ADMINISTRATION ADMINISTRATIVE SERVICES PRINTING GENERAL PRINTING PROCUREMENT (HEADQUARTERS) Transmittal Number 97-34 -- Date: 04/30/1997 1.
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What is smg h2205 - fda?
smg h2205 - fda is a form required by the Food and Drug Administration (FDA) for the submission of medical device reports (MDRs).
Who is required to file smg h2205 - fda?
Manufacturers, importers, and device user facilities are required to file smg h2205 - fda.
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To fill out smg h2205 - fda, you need to provide information about the medical device, the adverse event or product problem, and submit the form electronically through the FDA's online portal.
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The purpose of smg h2205 - fda is to allow for the timely reporting and tracking of adverse events and product problems related to medical devices.
What information must be reported on smg h2205 - fda?
Information such as the type of medical device, the adverse event or product problem, any injuries or deaths associated with the device, and contact information for the reporter must be reported on smg h2205-fda.
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