510(k) Executive Summary vs 510(k) Summary - Differences

R

rwend07

Involved In Discussions
When reading over the descriptions for 510(k) summaries and 510(k) executive summaries they sound pretty much the same. Section 10 "executive summary" sounds exactly like what is provided in the regular 510(k) summaries that are released to the public. Are there any differences that I'm missing in comparing the two? Thanks for any insight in advance.
 
shimonv

shimonv

Trusted Information Resource
Hi rwend07,
In a nutshell the executive summary is an elaborate version of the 510(k) summary, which is available to the public. For example, the predicate device is identified in the 510(k) summary but the executive summary includes a comparison table between the new and the predicate device.
Another example, the 510(k) summary includes non-clinical performance data but the executive summary includes more details (standards, spec, etc.).

I view the executive summary as in introduction to the reviewer while the 510(k) summary is the abbreviated version for the public. I am not aware of any type of mandatory information in the executive summary which is not mentioned in the 510(k) summary.

Cheers,
Shimon
 
R

rwend07

Involved In Discussions
shimonv said:
Hi rwend07,
In a nutshell the executive summary is an elaborate version of the 510(k) summary, which is available to the public. For example, the predicate device is identified in the 510(k) summary but the executive summary includes a comparison table between the new and the predicate device.
Another example, the 510(k) summary includes non-clinical performance data but the executive summary includes more details (standards, spec, etc.).

I view the executive summary as in introduction to the reviewer while the 510(k) summary is the abbreviated version for the public. I am not aware of any type of mandatory information in the executive summary which is not mentioned in the 510(k) summary.

Cheers,
Shimon
Click to expand...

Perfect explanation, thank you.
 
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