HHS Form FDA 3613 2015 free printable template
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Form Approved: OMB No. 09100498; Expiration Date: xx/xx/201xSUPPLEMENTARY INFORMATION
CERTIFICATE TO FOREIGN GOVERNMENT REQUESTSDepartment of Health and Human Services
Food and Drug Administration
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How to fill out HHS Form FDA 3613
01
Begin by downloading HHS Form FDA 3613 from the FDA website.
02
Fill in your personal information in the designated fields, including name, address, and contact information.
03
Specify the type of application or submission you are making under the appropriate section.
04
Provide details about the subject of your submission, including relevant identification numbers.
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Describe the purpose of the form and any specific requests or actions you are seeking.
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Review the instructions to ensure all required fields are completed accurately.
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Sign and date the form where indicated.
08
Submit the completed form according to the FDA guidelines, either by mail or electronically.
Who needs HHS Form FDA 3613?
01
Individuals or organizations involved in FDA-regulated activities.
02
Manufacturers of medical devices, biologics, or pharmaceuticals seeking to submit applications.
03
Researchers conducting clinical trials that require FDA oversight.
04
Entities involved in the importation of FDA-regulated products.
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What is HHS Form FDA 3613?
HHS Form FDA 3613 is a form used by manufacturers to report the establishment of a new medical device or a change to an existing device that meets certain criteria set forth by the FDA.
Who is required to file HHS Form FDA 3613?
Manufacturers of medical devices that are subject to FDA regulations are required to file HHS Form FDA 3613 when they introduce a new device or modify an existing one.
How to fill out HHS Form FDA 3613?
To fill out HHS Form FDA 3613, manufacturers must provide specific information about the device, including its name, intended use, detailed specifications, and any changes being made compared to previously approved devices.
What is the purpose of HHS Form FDA 3613?
The purpose of HHS Form FDA 3613 is to ensure that the FDA is informed about new or modified medical devices that may impact public health and safety, allowing for appropriate oversight and regulation.
What information must be reported on HHS Form FDA 3613?
The form requires information such as the manufacturer's name, device description, intended use, classification information, and any changes made to the device from its previous version.
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