Hi,

Sometimes we receive a Guidance document from the FDA, and because we are pressed for time (or for other reasons), we fail to pay attention to an important detail in the Guidance document.

NOTE that the recommended format for the content of a 510(k) submittal as set out in the FDA Guidance Document entitled "Format for Traditional and Abbreviated 510(k)s", dated 12 August, 2005, does NOT set out a format for Special 510(k) submittals, but only for Traditional and Abbreviated 510(k)s.

Also, Section 10 of the above document (Executive Summary) requires the submitter to include a device comparison table with an outline of the differences and similarities between the new device and the predicate device.

Section 12 of the above document (Substantial Equivalence Discussion) requires the submitter to include a "detailed comparison between your device and the predicate sufficient to demonstrate the substantial equivalence of the devices".

I queried this with the FDA, and was told that "it is the same table. The FDA supervisors would like to see a concise executive summary section that includes the table from section 12." In other words, the same table applies to both Sections 10 and 12.

Regards,

Asherlee