Get Hhs Form Fda 3674 2023

This guide provides a comprehensive overview of how to fill out the HHS Form FDA 3674 online. Designed for individuals unfamiliar with legal documents, this step-by-step approach ensures clarity and accessibility for all users.

Follow the steps to complete and submit the form online.

1. Click ‘Get Form’ button to obtain the form and access it in your preferred editing tool.
2. Enter the name of the sponsor, applicant, or submitter in the designated field. Ensure that this name matches the one listed on the application or submission.
3. Provide the date of the application or submission in the next field. If the certification is submitted later, use the date of submission.
4. Fill in the complete address of the sponsor or applicant, including street address, city, state, and postal code. Also, enter the telephone and fax numbers, including the country code where applicable.
5. For the product information, depending on whether your submission is for drugs, biologics, or devices, include all relevant names and classifications. Use a continuation page if necessary to include all details.
6. Select the type of application or submission that this certification accompanies by checking the appropriate box.
7. If applicable, provide the previously assigned IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP number associated with your application or submission.
8. If a serial number has been assigned to your submission, enter it in the designated field. If not, you can leave it blank.
9. In the certification section, check the appropriate box based on the status of the clinical trials related to your submission.
10. If Box C is checked, provide the National Clinical Trial (NCT) numbers for the trials that require compliance. Use a continuation page if needed.
11. Input the name and title of the individual signing the certification, ensuring they are authorized to do so.
12. Provide the address and contact information of the signer.
13. Enter the date when the certification is signed.
14. The authorized person must sign the form in the specified section.
15. After completing all fields, review the information for accuracy. You can then save the changes, download, print, or share the completed form as necessary.

Complete your HHS Form FDA 3674 online today to ensure your submission is accurate and compliant.