The FDA describes the Premarket Notification 510(k) Database in the following way:
"A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval."
A longer introduction to Premarket Notification 510(k) is also available.
The file layout describes the data fields.
The FDA offers many helpful, additional resources such as the following:
The complete FDA Premarket Notification database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.
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|Last Update||Created by Jean Roth June 29, 2014|