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Save As... Print Next Page Reset Form Approved: OMB No. 0910-0498; Expiration Date: 3/31/09 Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied
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What is fda form 3613 d?
FDA Form 3613 d is a form used by medical device establishments to report adverse events related to medical devices.
Who is required to file fda form 3613 d?
Medical device establishments are required to file FDA Form 3613 d.
How to fill out fda form 3613 d?
To fill out FDA Form 3613 d, you will need to provide information about the medical device, the adverse event, and any actions taken by the establishment in response to the event. The form can be filled out electronically or submitted via mail.
What is the purpose of fda form 3613 d?
The purpose of FDA Form 3613 d is to enable medical device establishments to report adverse events to the FDA, which helps in monitoring the safety and effectiveness of medical devices.
What information must be reported on fda form 3613 d?
FDA Form 3613 d requires the reporting of information such as the device identification, details of the adverse event, patient information, and any corrective actions taken.
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