Databases on the FDA Website
The search engine on the FDA Website will not find information that is in the databases that make up a large part of the site. Those databases can be accessed separately, using the links below. Following each link is a brief description of the database.
Animal Feed and Drugs
FDA Approved Animal Drug Products: A listing of searchable databases in the following categories: Approved Animal Drug Products (Basic search), Approved Animal Drug Products (Advanced search), Suitability Petitions, Sponsors, Green Book, Code of Federal Regulations, Federal Register, Patents, and Exclusivity.
FDA BSE/Ruminant Feed Inspections Firms Inventory: Inspection information of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others regarding compliance with the BSE/Ruminant Feed regulations.
Biological Products
Adverse Event Reporting System: The Adverse Event Reporting System is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
Biological Product Deviation Reports (BioDev): Records Incoming Biological Product Deviation Reports for CBER.
Vaccine Adverse Event Reporting System (VAERS): VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events that occur after the administration of U.S. licensed vaccines.
Drugs
Adverse Event Reporting System: The Adverse Event Reporting System is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book): Listing of drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.
Drugs@FDA: A searchable and browsable catalog of information about brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. Search by drug name or active ingredient.
Drug Firm Annual Registration Status: Allows firms manufacturing drug products to register the site where the product was made within 5 days of commercial distribution and re-register annually, updating and validating current site information as required by section 510 of the Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations 21 CFR part 207.
Inactive Ingredient Search for Approved Drug Products: Database provides ability to search for inactive ingredients in approved drug products.
National Drug Code Directory: The NDC serves as universal product identifier for human drugs.
Oncology Tools: Provides several tools relating to the use of oncology drugs.
Postmarketing Study Commitments: Provides information to the public on postmarketing study commitments, also called phase 4 commitments. Postmarketing study commitments are studies — required of or agreed to by a sponsor — that are conducted after FDA has approved a product for marketing (e.g., studies requiring the sponsor to demonstrate clinical benefit of a product following accelerated approval). FDA uses postmarketing study commitments to gather additional information about a product’s safety, efficacy, or optimal use.
Medical Devices
510(k)s--Premarket Notifications (PMN): This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.
Advisory Committee/Panel Meetings: Contains information about upcoming CDRH Advisory Committee and Panel meetings. Historical information and links to summaries and/or transcripts are provided for recent past meetings.
Assembler Database: Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the releasable information submitted including Equipment Location, General Information and Component Information. Note: Data does no include dental system installations.
CDRH Document Database (index to the Center for Devices and Radiological Health Web Pages): Produces CDRH topic index on demand.
Clinical Laboratory Improvement Amendments (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.
Device Listing: This database contains a listing of medical devices in commercial distribution by both domestic and foreign manufacturers.
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.
Good Guidance Practice: Contains the current comprehensive list of all CDRH guidance documents. The term 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; the design, production, manufacturing, and testing of regulated products; or to the inspection and enforcement procedures.
Mammography Quality Standards Act - MQSA: 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.
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 usese the device is approved for, when it can be used, and when it should not be used.
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.
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).
Premarket Approval (PMA): Users can search for information on premarket approval status of manufacturers.
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 Search: 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. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in an of itself, however, may not always be a sufficient basis for regulatory decisions.
United States Agents for Devices: This database acts as an "electronic bulletin board" where the public can post their availability of being a U.S. Agents for medical devices. The database is searchable and users can add to or inactivate their own information.
Y2K Biomedical Equipment Clearing House: This database and search mechanism permits the searching for the Y2K status of biomedical equipment.
Animal Feed and Drugs
FDA Approved Animal Drug Products: A listing of searchable databases in the following categories: Approved Animal Drug Products (Basic search), Approved Animal Drug Products (Advanced search), Suitability Petitions, Sponsors, Green Book, Code of Federal Regulations, Federal Register, Patents, and Exclusivity.
FDA BSE/Ruminant Feed Inspections Firms Inventory: Inspection information of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others regarding compliance with the BSE/Ruminant Feed regulations.
Biological Products
Adverse Event Reporting System: The Adverse Event Reporting System is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
Biological Product Deviation Reports (BioDev): Records Incoming Biological Product Deviation Reports for CBER.
Vaccine Adverse Event Reporting System (VAERS): VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events that occur after the administration of U.S. licensed vaccines.
Drugs
Adverse Event Reporting System: The Adverse Event Reporting System is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book): Listing of drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.
Drugs@FDA: A searchable and browsable catalog of information about brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. Search by drug name or active ingredient.
Drug Firm Annual Registration Status: Allows firms manufacturing drug products to register the site where the product was made within 5 days of commercial distribution and re-register annually, updating and validating current site information as required by section 510 of the Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations 21 CFR part 207.
Inactive Ingredient Search for Approved Drug Products: Database provides ability to search for inactive ingredients in approved drug products.
National Drug Code Directory: The NDC serves as universal product identifier for human drugs.
Oncology Tools: Provides several tools relating to the use of oncology drugs.
Postmarketing Study Commitments: Provides information to the public on postmarketing study commitments, also called phase 4 commitments. Postmarketing study commitments are studies — required of or agreed to by a sponsor — that are conducted after FDA has approved a product for marketing (e.g., studies requiring the sponsor to demonstrate clinical benefit of a product following accelerated approval). FDA uses postmarketing study commitments to gather additional information about a product’s safety, efficacy, or optimal use.
Medical Devices
510(k)s--Premarket Notifications (PMN): This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.
Advisory Committee/Panel Meetings: Contains information about upcoming CDRH Advisory Committee and Panel meetings. Historical information and links to summaries and/or transcripts are provided for recent past meetings.
Assembler Database: Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database contains the releasable information submitted including Equipment Location, General Information and Component Information. Note: Data does no include dental system installations.
CDRH Document Database (index to the Center for Devices and Radiological Health Web Pages): Produces CDRH topic index on demand.
Clinical Laboratory Improvement Amendments (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.
Device Listing: This database contains a listing of medical devices in commercial distribution by both domestic and foreign manufacturers.
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.
Good Guidance Practice: Contains the current comprehensive list of all CDRH guidance documents. The term 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; the design, production, manufacturing, and testing of regulated products; or to the inspection and enforcement procedures.
Mammography Quality Standards Act - MQSA: 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.
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 usese the device is approved for, when it can be used, and when it should not be used.
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.
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).
Premarket Approval (PMA): Users can search for information on premarket approval status of manufacturers.
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 Search: 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. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in an of itself, however, may not always be a sufficient basis for regulatory decisions.
United States Agents for Devices: This database acts as an "electronic bulletin board" where the public can post their availability of being a U.S. Agents for medical devices. The database is searchable and users can add to or inactivate their own information.
Y2K Biomedical Equipment Clearing House: This database and search mechanism permits the searching for the Y2K status of biomedical equipment.
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