CDRH Export Certification Application and Tracking System (CECATS) is CDRH’s online portal for manufacturers to request export certificates, simple notifications, and export permit letters. In November 2012, the first phase introduced the submission of requests for a Certificate to Foreign Government electronically through CECATS. CECATS is an alternative to paper submissions and offers several benefits, including a reduction in certificate processing time, savings on material and mailing costs for paper applications, real-time validation of firm-specific data, and status updates for the request.
In order to implement electronic submission of all export documents and continually improve the user experience, CECATS has gone through a series of enhancements:
In March 2013, CECATS was enhanced to allow manufacturers to submit requests for Certificates of Exportability under sections 801(e)(1) and 802 of Chapter VIII of the Federal Food, Drug, and Cosmetic Act.
In February 2014, CDRH made a series of enhancements which allowed users to make changes to an application prior to review, upload additional documents such as mailing labels, and clone export certificates requested under sections 801 and 802.
In September 2014, we made additional enhancements to allow manufacturers to submit requests for Non-Clinical Research Use Only certificates via CECATS.
On February 10, 2015, the FDA added the ability to request Export Permit Letters and Simple Notifications via CECATS.
In 2016, we enabled direct editing of the product list in a cloned CECATS application, as well as the ability to Save & Continue at any step.
In September 2017, enhancements included a new user interface for CECATS with updated icons and a user-friendly layout as well as the ability to enter an alternate email address and Save & Exit in section 4 of a Certificate to Foreign Government application. An alternate email address is an option to list the email address of the actual requestor to ease communication during the review process.
