Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval.The export provisions under section 802 of the FD&C Act only applies to unapproved devices. For a device to be legally in commercial distribution in the U.S., the following requirements must be met:
Device Registration and Listing
In addition, the U.S. exporter must comply with the laws of the importing country.
- The manufacturing facility must be registered with FDA;
- The device must be listed with FDA;
- The device must have a cleared Premarket Notification 510(k) or Premarket Approval (PMA) unless exempted by regulation or if the device was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act);
- The device must meet the labeling requirements of 21 CFR Part 801and 21 CFR 809, if applicable;
- The device must be manufactured in accordance with the Quality Systems (QS) Regulation of 21 CFR Part 820 (also known as Good Manufacturing Practices or GMP), unless exempted by regulation.
Please note that U.S. manufactures that export medical devices outside the U.S. are required to register their facility and list their devices (21 CFR 807).