Export of Non-FDA Approved or Cleared to Market Devices

The following summary is provided with regard to export of a medical device without FDA clearance to market by 510(k), Pre Market Approval by PMA or export approval. A device can be exported without FDA device marketing approval in the United States, if it complies with the following requirements:

In compliance with the Food, Drug and Cosmetic Act Section 802, the FDA does not approve the export of the device and the device can be exported to any country if:

Prior to export, a notification of export is provided to the FDA.

For support with FDA and International regulations, contact:

Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589
E-mail: QRASupport@AOL.com
Phone: 608 877-2635
Fax: 608 873-7382

Go back to QRA Home Page


Updated: April 26, 2001