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See Instructions for OMB Statement. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION(FDA Establishment Identifier)ESTABLISHMENT REGISTRATION AND LISTING FOR
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How to fill out form fda 3356 804
How to fill out form fda 3356 804
01
Obtain a copy of form FDA 3356 804 from the FDA website or local FDA office.
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Fill in all relevant personal information such as name, address, and contact details.
04
Provide details of the product being reviewed including its classification, intended use, and any relevant marketing history.
05
Include any supporting documentation or information requested on the form.
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Double check the completed form for accuracy and completeness before submitting it to the FDA.
Who needs form fda 3356 804?
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Any individual or organization that is seeking FDA approval for a new medical device, drug, or biologic product needs form FDA 3356 804.
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What is form fda 3356 804?
Form FDA 3356 804 is a form used to report adverse events and product problems related to medical devices.
Who is required to file form fda 3356 804?
Manufacturers, importers, and device user facilities are required to file form FDA 3356 804.
How to fill out form fda 3356 804?
Form FDA 3356 804 can be filled out online on the FDA's website or submitted through mail or fax. The form requires information about the device, the adverse event, and contact details.
What is the purpose of form fda 3356 804?
The purpose of form FDA 3356 804 is to provide a way for stakeholders to report adverse events and product problems related to medical devices to the FDA.
What information must be reported on form fda 3356 804?
Information such as device details, patient information, the adverse event or problem, and contact details must be reported on form FDA 3356 804.
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