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FDA 2301 2012 free printable template

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Section TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS (See Instructions on Back) 2. NAME OF APPLICANT 1. NASA NO. or CANADA NO. 2301 Form Approved: OMB No. 0910-0284
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How to fill out FDA 2301

01
Obtain a copy of FDA Form 2301 from the FDA website.
02
Fill out the 'Applicant Information' section with your name and contact details.
03
Provide a description of the device or product in the 'Product Information' section.
04
Indicate the purpose of the submission in the 'Submission Type' section.
05
Sign and date the form to certify the information provided is accurate.
06
Submit the completed form along with any required attachments to the FDA.

Who needs FDA 2301?

01
Manufacturers of medical devices.
02
Importers intending to bring medical devices into the U.S.
03
Distributors of medical devices seeking clearance or registration.
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FDA 2301 is a form used by the U.S. Food and Drug Administration (FDA) for the reporting of adverse events related to medical devices.
Manufacturers, importers, and user facilities are required to file FDA 2301 when they become aware of adverse events involving a medical device.
To fill out FDA 2301, provide detailed information about the device, patient demographics, the adverse event description, and any corrective actions taken.
The purpose of FDA 2301 is to assist the FDA in monitoring the safety and effectiveness of medical devices by collecting information on adverse events.
Information that must be reported on FDA 2301 includes the device identification, event details, patient information, and any corrective actions taken.
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