Get Form 3654: Standards Data Report For 510(k)s

The Form 3654: Standards Data Report For 510(k)s is a crucial document required when submitting a 510(k) that references a national or international standard. This guide provides a detailed, step-by-step approach to completing the form online, ensuring you meet all necessary requirements.

Follow the steps to fill out the Form 3654 effectively.

1. Click the ‘Get Form’ button to obtain the form and open it in your preferred editor.
2. Identify the type of 510(k) submission you are completing by selecting from the options: Traditional, Special, or Abbreviated. This selection is crucial as it impacts the review process.
3. Fill out the 'Standard Title 1' field by providing the appropriate standard’s title. Ensure you follow the formatting convention specified in the form if applicable.
4. Respond to the subsequent questions regarding the standard being referenced. Use 'Yes' or 'No' options where required. Pay special attention to questions regarding FDA recognition, third-party testing, and inclusion of summary reports.
5. If the response to any question indicates a need for a summary report table, complete that section. This table should detail all relevant sections of the standard, along with the conformance status, any deviations, and justifications for those deviations.
6. Review each section thoroughly to ensure accuracy, particularly focusing on any requirements for adaptations or exclusions from the standard.
7. Once all sections are completed, review the form for completeness. You have options to save changes, download, print, or share the document as needed.

Start filling out your Form 3654 online today for a smooth 510(k) submission process.