Only class III devices that do not require a PMA submission should have a summary and certification, and they should be included in the 510(k) documentation. The Class III Summary is a list of issues related to the device’s safety and effectiveness.
It must provide a complete description of information on the item as well as other lawfully marketed devices, as well as citations to such data if applicable. I devised this part is not applicable for classes II and Class, and can insert the statement “This section does not apply” or “N/A” under that heading.
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