NATIONAL BUREAU OF ECONOMIC RESEARCH
NATIONAL BUREAU OF ECONOMIC RESEARCH

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 ยง807.92(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.

Updates and changes.

Time Period
Source Data File
Premarket Notification
Source
Stata
Stata 244
SAS
CSV
Desc
Most current month available
pmnlstmn.zip
txt
dta
dta
sas7bdat
csv
desc
1996-current
pmn96cur.zip
txt
dta
dta
sas7bdat
csv
desc
1991-1995
pmn9195.zip
txt
dta
dta
sas7bdat
csv
desc
1986-1990
pmn8690.zip
txt
dta
dta
sas7bdat
csv
desc
1981-1985
pmn8185.zip
txt
dta
dta
sas7bdat
csv
desc
1976-1980
pmn7680.zip
txt
dta
dta
sas7bdat
csv
desc
Pre-Stata13 had a string length limit of 244 characters.

To report problems or if you have comments or suggestions , e-mail Jean Roth at jroth@nber.org

Last Update Created by Jean Roth June 29, 2014
 
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