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General Links
- Code of Federal Regulation (CFR)
- 21 CFR
- US Federal Register
Center Links
- US Food and Drug Administration (FDA)
- Center for Devices and Radiological Health (CDRH)
- Center for Drugs Evaluation and Research (CDER)
- Center for Tobacco Products (CTP)
- Center for Food Safety and Nutrition (CFSAN)
- Center for Veterinary Medicine (CVM)
FDA Resource Links and Databases
- General Resource Links
- Federal Advisory Committees and Meeting Materials
- FDA Disbarment List
- Medical Device Compliance and Enforcement Portal
- Inspections Database
- Searchable Warning Letters Database
- Clinical Investigators – Disqualification Proceedings
- Institutional Review Boards – Restrictions Imposed Letters and Disqualification Proceedings
- FDA Data Dashboard
- Drugs Resource Links
- FDA Adverse Event Reporting System (FAERS) (formerly AERS)
- Bioequivalence (BE) Recommendations for Specific Products
- Bioresearch Monitoring Information System (BMIS)
- Clinical Investigator Inspection List (CLIIL)
- Dissolution Methods Database
- Drugs@FDA
- Inactive Ingredient Search for Approved Drug Products
- National Drug Code Directory
- Orange Book (Approved Drug Products with Therapeutic Equivalence)
- Postmarket Requirements and Commitments
- Medical Device Databases
- CLIA Database
- Clinical Laboratory Improvement Amendments – Currently Waived Analytes
- Over The Counter Database
- 522 Postmarket Surveillance Studies Program
- AccessGUDID (Global Unique Device Identification Database)
- Advisory Committee/Panel Meetings – CDRH (No longer being updated)
- CDRH Export Certificate Validation (CECV)
- CFR Title 21 – Food and Drugs
- Clinical Laboratory Improvement Amendments (CLIA)
- CLIA Currently Waived Analytes
- De Novo
- Devices@FDA
- FDA Certified Mammography Facilities
- Humanitarian Device Exemption (HDE)
- IVD Home Use Lab Tests (Over The Counter) Tests
- MAUDE (Manufacturer and User Facility Device Experience)
- MDR (Medical Device Reporting)
- MedSun Reports
- Post-Approval Studies (PAS) Database
- Premarket Approvals (PMA)
- Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
- Premarket Notifications (510(k)s)
- Product Classification
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- Recalls of Medical Devices
- Recognized Consensus Standards
- Registration & Listing
- Total Product Life Cycle (TPLC)
- X-Ray Assembler Data