Manufacturers can now submit export document requests online under a new FDA program. The agency announced the CDRH Export Certification and Tracking System (CECATS) in a recent letter to industry. CECATS will initially be available for Certificates to Foreign Governments, which make up 95 percent of the export document requests the device center receives. In 2013, the program will expand to offer Certificates of Exportability, Non-Clinical Research Use Only Certificates, Simple Notifications of Medical Device Exports and Export Permit Letters.
The GMP Letter