Dr Dunning's note from 2004 has been replaced by this 2010 text:

March 23, 2010
Export and import materials are now at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance. When on this page, select "Importing and Exporting Devices" from the menu at the left side. This page allows selection of the materials on procedures and costs for obtaining a Certificate of Exportability or Certificate to a Foreign Government, and now contains information regarding the import of medical devices as well.

Alternately, this material may be reached by going to the medical devices home page: www.fda.gov/MedicalDevices, then selecting "Device Advice: Device Regulation and Guidance" (near mid-page, to the left); now select "Importing and Exporting Devices" as above.

H. Neal Dunning
NEAL DUNNING ASSOCIATES
e-mail: hndunning@comcast.net
26420 SUMMER GREENS DR.
BONITA SPRINGS, FL 34135
PH: 239-498-9153 or 1571
FAX: 239-498-9153