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Get Fda 3654 2014-2026
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How to fill out the FDA 3654 online
The FDA 3654 form is essential for applicants submitting a 510(k) that references a national or international standard. This guide provides clear, step-by-step instructions to assist users in completing the form accurately and efficiently online.
Follow the steps to fill out the FDA 3654 form effectively.
- Click ‘Get Form’ button to obtain the form and open it in the online editor.
- Choose the type of 510(k) submission by selecting one of the options: traditional, special, or abbreviated. Ensure it aligns with the nature of your submission.
- Provide the standard title as required. Follow the formatting convention: [SDO] [numeric identifier] [title of standard] [date of publication].
- Answer each question regarding FDA recognition, testing laboratory responsibility, and inclusion of a summary report. Be truthful and thorough in your responses.
- Complete the extent of standard conformance section. Indicate if the device conforms to the standard requirements and provide justifications for any deviations or exclusions.
- For each section of the standard, confirm conformance, and if not applicable, provide appropriate justifications.
- Review the entries made throughout the form for completeness and accuracy. Make any necessary edits before proceeding.
- Once satisfied with the completed form, save changes, download a copy for your records, and print or share the form as needed.
Complete your FDA 3654 form online today for a smoother submission process.
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