The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.
See the FAERS web site for download information.
FDA dataset that contains medical device adverse event reports submitted by mandatory reporters—manufacturers, importers and device user facilities—and voluntary reporters such as health care professionals, patients, and consumers.
See the MAUDE web site for download information.
The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls.
See the RES web site for download information.
Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
See the SPL web site for download information.
Comprehensive NDC SPL Data Elements.
See the NDC web page for download information.
Tobacco Product Problem Reports.
See the Tobacco Product Problem Reports for download information.