How to Search Food & Drug Administration (Start Here)
FDA databases cover drug approvals, medical device listings, food safety, adverse event reports, and import alerts.
What this page covers: FDA drug databases (Orange Book, Drugs@FDA), device databases (510(k), PMA), food recalls, and adverse event reporting. What it does not cover: Meat and poultry safety (that is USDA).
Where to start: For approved drugs, use Drugs@FDA or the Orange Book. For medical devices, use the 510(k) or PMA databases. For adverse events, use FAERS. For food recalls, use the FDA recall database.
What Each System Returns vs Excludes
| Database | Returns | Excludes |
|---|---|---|
| Recalls | Product recalls, classifications, distribution, firm info | Voluntary market withdrawals (sometimes) |
| Inspections | Facility inspections, citations, warning letters | State/local health inspections |
| FAERS | Adverse event reports, suspect drugs, outcomes | Confirmed causation (reports only) |
| Drugs@FDA | Approved drugs, labels, approval history | Pipeline drugs, clinical trial results |
Advisory Committee & FDA Panel Meetings
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Index of upcoming and past FDA CDRH Advisory Committee and Panel meetings.
Animal Drug Approved Products (Green Book)
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FDA Green Book database of animal drug approved products.
Approved Drug Products
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FCA Center for Drug Evaluation and Research catalog of approved drug products.
Approved Drug Products | FDA Orange Book
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FDA Orange Book of Approved Drug Products with Therapeutic Equivalence Evaluations.
Clinical Laboratory Improvement Amendments (CLIA)
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The CLIA database contains the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000 and test categorized by the.
Drug Code Directory
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The NDC serves as universal product identifier for human drugs. Search by proprietary name, active ingredient, NCC number, or firm name.
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FDA Warning Letters
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General, Tobacco Retailer, and Drug marketing warning letters from the FDA.
Federal Register Notices
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Administers, searches and retrieves Federal Register Notices for the US Food and Drug Administration.
Good Guidance Practice Documents
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Contains the current index of all medical device guidance documents.
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Medical Device Adverse Events (MAUDE)
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MAUDE data represents reports of adverse events involving medical devices.
Medical Device Approvals
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FDA medical device application denials, approvals, and clearances.
Medical Device Failures
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FDA index of medical devices which may have malfunctioned or caused a death or serious injury.
Medical Device Premarket Approval (PMA)
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FDA medical device database of information on premarket approval status of manufacturers.
Medical Devices and Establishment Registration
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This is a searchable database of domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing.
Products Classification
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Contains medical device names and associated information. Users can search this database by either medical specialty or name of device.
Radiation Emitting Electronic Product Codes
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FDA index of product codes for radiation emitting devices.
Recognized Consensus Standards
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Database of national and international standards recognized by the FDA.
Seafood List (RFE)
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FDA Regulatory Fish Encyclopedia (Seafood List) of acceptable market names for imported and domestically available seafood as well as scientific.
X-Ray Assembler Database
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X-Ray assemblers and installers are required by the FDA to submit reports of assembly following assembly completion.
Frequently Asked Questions
What is the Orange Book? ▼
A list of FDA-approved drug products with therapeutic equivalence evaluations — the reference for identifying generic equivalents.
Can I report a drug side effect? ▼
Yes. Use FDA MedWatch to report adverse events related to drugs, medical devices, or other FDA-regulated products.
What is the difference between 510(k) and PMA? ▼
A 510(k) shows a device is equivalent to an existing approved device. A PMA is a more rigorous review for high-risk devices.
Other Federal Databases
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