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Draft Guidance for Industry and Food and Drug Administration Staff Medical Device Reporting for Manufacturers DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.
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What is medical device reporting for?
Medical device reporting is for manufacturers, importers, and device user facilities to report any adverse events or product problems associated with medical devices.
Who is required to file medical device reporting for?
Manufacturers, importers, and device user facilities are required to file medical device reporting.
How to fill out medical device reporting for?
Medical device reporting can be filled out online through the FDA's MedWatch portal.
What is the purpose of medical device reporting for?
The purpose of medical device reporting is to monitor and detect potential safety issues with medical devices.
What information must be reported on medical device reporting for?
Information such as adverse events, malfunctions, and product problems associated with the medical device must be reported on medical device reporting.
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