3654-2025

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4.9 out of 5

40 votes

The document is a Standards Data Report for 510(k) submissions to the FDA, which must be completed by applicants referencing national or international standards. It outlines the requirements for reporting conformity to these standards, including questions about FDA recognition, third-party testing, deviations, and guidance documents. The report includes a summary table for detailing conformance with specific standard sections and justifications for any deviations or options selected.

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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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