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View Full Version : Submission of 510(k) - Does the FDA require a predefined structure of the content? temujin 27th June 2007, 08:31 AM 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 Gert Sorensen 27th June 2007, 08:40 AM Maybe this site can help you: http://www.fda.gov/cdrh/510khome.html :bigwave: Asherlee 2nd July 2007, 11:49 AM 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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