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People Helping People Build a Safer World People Helping People Build a Safer World-beating New Partnerships Creating New Partnerships & United For Safer Buildings ICC Upper Great Plains Region III
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What is a safer?
A safer is a form used to report adverse events and product problems associated with medical devices.
Who is required to file a safer?
Manufacturers, importers, and device user facilities are required to file a safer.
How to fill out a safer?
A safer can be filled out online through the FDA's MedWatch website or by submitting a paper form.
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The purpose of a safer is to help the FDA monitor the safety and performance of medical devices.
What information must be reported on a safer?
Information such as the device type, adverse event description, patient impact, and reporter contact information must be reported on a safer.
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