July 14, 2004
The FDA recently released a general guidance document covering the issue of Export Certificates. This is a general document covering Foods, Drugs, Cosmetics, and Biologics as well as Medical Devices. As far as device is concerned, there is little new material in it. However, it does give an internet reference back to the usual material on medical devices: www.fda.gov/cdrh/devadvice/39.html. This address takes one to the materials on procedures and costs for obtaining a Certificate of Exportability or Certificate to a Foreign Government and is most useful.

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