3674 fda form-2026

1. Click ‘Get Form’ to open the 3674 FDA form in the editor.
2. Begin by entering the 'Name of Sponsor/Applicant/Submitter' in the designated field. Ensure this matches exactly with what is listed on your application.
3. Next, input the 'Date of the Application/Submission' that this certification accompanies.
4. Provide complete contact information, including 'Address', 'Telephone', and 'Fax Numbers' for the sponsor/applicant/submitter.
5. In the 'Product Information' section, specify all relevant names for drugs/biologics or devices as required. Attach extra pages if necessary.
6. Select the type of application/submission by checking the appropriate box in section six.
7. If applicable, include any previously assigned IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP number in section seven.
8. Fill in any serial number associated with your application in section eight, if available.
9. Check one of the boxes under 'Certification Statement' based on your situation regarding clinical trials.
10. If you checked Box C, provide any National Clinical Trial (NCT) numbers related to applicable clinical trials.
11. Sign and date where indicated to complete your submission. Ensure that all information is accurate and complete before finalizing.

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