Form 3674 pdf-2026

1. Click ‘Get Form’ to open it in the editor.
2. Begin by entering the 'Name of Sponsor/Applicant/Submitter' in the designated field. Ensure this matches exactly with the application.
3. Input the 'Date of the Application/Submission' that this certification accompanies.
4. Fill in the complete 'Address' including number, street, state, and ZIP code for accurate identification.
5. Provide your 'Telephone and Fax Numbers' including area codes to facilitate communication.
6. In the 'Product Information' section, specify all relevant names for drugs/biologics or devices as required.
7. Select the appropriate 'Type of Application/Submission' by checking one of the boxes provided.
8. If applicable, enter any previously assigned IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP number in the corresponding field.
9. Check one box under 'Certification Statement' based on your assessment regarding clinical trials referenced in your submission.
10. If you checked Box C, provide any National Clinical Trial (NCT) numbers related to applicable clinical trials.
11. Sign in the designated area and include your name and title below your signature.
12. Complete your contact information again for verification purposes and provide the date of certification at the end.

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