FDA Resources
FDA's Home Page
FDA's Compliance Program Guidance Manual for FDA Staff
FDA Compliance Policy and Regulatory Action Guidance
Regulatory Procedures manual for use by FDA Personnel
FDA's Inspection References
FDA's Guides to Inspections (for FDA investigators)
Inspectors Technical Guides (older guidance documents.)
Investigations Operations Manual (IOM) for FDA Investigators
FD-483s Frequently requested from FDA through Freedom of Information
Warning Letters on FDA's Website
Enforcement Reports (recalls, seizures, etc.)
FDA Personnel Contact Numbers by Office/Region
Quality System Inspection Technique-QSIT (for medial devices)
FDA Databases (MDR, Establishment Registrations, Product Approval Lists)
Search Code of Federal Regulations, Title 21 (Food and Drugs)
Search Federal Register Notices
Search FDA Guidance Documents
Regulatory Glossary
Medical Device Small Entity Compliance Guide (Quality System Manual)
"Device Advice" from FDA (Referances and General Information for Medical Devices)


Other Resources
Regulatory Affairs Professional Society (RAPS)
Institute of Validation Technology (IVT)
Association for the Advancement of Medical Instrumentation (AAMI)
International Society of Pharmaceutical Engineering (ISPE)
Advanced Medical Technology (AdvaMed)
Organization of Regulatory and Clinical Associates (ORCA)
Global Harmonization Task Force (GHTF)