3654-2026

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4.9 out of 5

40 votes

The document is a form from the Department of Health and Human Services, specifically the Food and Drug Administration (FDA), used for submitting a Standards Data Report for 510(k) applications that reference national or international standards. It outlines the requirements for applicants to report on conformity to standards, including questions about FDA recognition, testing laboratories, deviations, and guidance documents. The form emphasizes the need for detailed reporting on standard conformance and any adaptations made during the testing process.

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Click ‘Get Form’ to open the 3654 in the editor.
Begin by selecting the type of 510(k) submission: Traditional, Special, or Abbreviated. This is crucial as it determines the subsequent fields you will need to complete.
Fill in the 'Standard Title' section with the appropriate title of the standard referenced in your submission.
Answer the questions regarding FDA recognition and testing conformity. Ensure you provide accurate details for each question, including any necessary FDA recognition numbers.
If applicable, complete the summary report table by detailing conformance with standard sections. Indicate whether each section is met and provide justifications for any deviations or options selected.
Review all entries for accuracy and completeness before finalizing your form. Utilize our platform's features to save your progress and make edits as needed.

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Versions	Form popularity	Fillable & printable
2014	4.9 Satisfied (40 Votes)
2010	4.1 Satisfied (52 Votes)

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