Appendix C – FY 2005 OIVD Annual Report - Selected FDA Websites

OIVD Home Page -- http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm

CDRH’s Home Page -- http://www.fda.gov/MedicalDevices/default.htm

Division of Small Manufacturers, International and Consumer Assistance -- http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm

Federal Advisory Committee Act Database -- http://www.facadatabase.gov/public.asp

FDA’s Home Page -- http://www.fda.gov

Guidance Documents -- http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm

Instructions for Submitting Electronic Submissions -- http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm

Least Burdensome Provisions - Activities Related to Implementation -- http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceProvisionsofFDAModernizationAct/ucm136685.htm

MDUFMA Home Page -- http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm

Panel Meeting Schedules and Summaries -- http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/default.htm

Previously Approved/Cleared Device Databases -- http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm

Recent Device Approvals -- http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/Recently-ApprovedDevices/default.htm

Recruitment Brochure for Members and Consultants to the Medical Devices Advisory Committee --http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/ucm135904.htm

Standards of Ethical Conduct -- http://www.usoge.gov/ethics_docs/publications/reference_publications/rfsoc_02.pdf

Third Party Review -- http://www.fda.gov//MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm