Food & Drug Administration
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|Approved Drug Products Catalog |
Search the U.S. Food and Drug Administration Center for Drug Evaluation and Research catalog of approved drug products by brand name, generic name, active ingredient, and/or FDA action date.
|Assembler Database | X-Ray |
X-Ray assemblers and installers are required by the FDA to submit reports of assembly following assembly completion. Use this link to search the FDA X-Ray Assembler Database.
|Clinical Laboratory Improvement Amendments |
The CLIA database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000 and test categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.
|Drug Firm Status |
Search for FDA drug firm annual registration status by firm name.
|Good Guidance Practice |
Contains the current comprehensive list of all CDRH guidance documents. Guidance document refers to documents prepared for CDRH staff, regulated industry and the public that relate to the processing, content, and evaluation of regulatory submissions.
|Mammography Quality Standards |
Allows users to access a listing by state and zip code of all mammography facilities certified by the FDA as meeting baseline quality standards for equipment, personnel and practices under the Mammography Quality Standards Act of 1992 (MQSA).
|Medical Device Adverse Events (MAUDE) |
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
|Medical Device Approvals |
Products listed include some of the newest medical technology available. Each product listing contains information about what medical uses the device is approved for, when it can be used, and when it should not be used.
|Medical Device Listing |
This database contains a listing of medical devices in commercial distribution by both domestic and foreign manufacturers. Search by device name, owner/operator number, establishment registration number, product code, or advisory committee.
|Medical Device Reporting |
Allows users to search for information on medical devices which may have malfunctioned or caused a death or serious injury during years 1992 through 1996.
|Medical Devices and Establishment Registration |
This is a searchable database of domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution.
|National Drug Code Directory |
The NDC serves as universal product identifier for human drugs. Search by proprietary name, active ingredient, NCC number, or firm name.
|National Health Related Items Code (NHRIC) |
The National health Related Items code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as the National Drug Code (NDC) or Universal Product Code (UPC).
|Products Classification |
Contains medical device names and associated information. Users can search this database by either medical specialty or name of device.
|Recognized Consensus Standards |
Consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission.
|Seafood List (RFE) |
FDA Regulatory Fish Encyclopedia (Seafood List) of acceptable market names for imported and domestically available seafood as well as scientific names, common names, and known vernacular or regional names.