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Basic FDA Regulatory Guidance Information:

(Much more detailed information is provided in the book)

Devices:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm

Drugs:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Combination Products:

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm