FDA Premarket Notification 510(k) Database

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:

• Premarket Notification 510(k) searchable database
• CFR search engine.

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.

Updates and changes.

Contact data@nber.org with questions, comments, or suggestions.