Submission of 510(k) - Does the FDA require a predefined structure of the content?

T

temujin

#1
#1
Dear Forum

Can a 510(k) consist of a compilation of already existing documents or do the FDA require a certain predefined structure of the content?

regards
temu
 
GAGEpack - Gage & Calibration Management
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A

Asherlee

#3
#3
Re: Submission of 510(k) - Does the FDA require a predefined structure of the content

The FDA has published a guidance document which sets out the required format for a Traditional and an Abbreviated 510(k) - see the attached file.
Read this guidance document and you will save yourself a lot of time when you hand in your 510(k) submittal.

Regards,

Asherlee
 

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