Food and Drug Administration (FDA) is launching a new website to assist with the processing and submission of export document requests. The new electronic system will be a faster, easier and more affordable alternative to traditional paper submissions. The new export document request system is called the Expert Certification and Tracking System.
The FDA expects the new system to reduce processing times for certificates. In addition, the system will provide applicants a tool to check on the status of all submissions. However, the system is only available for export certificates that go to foreign governments. These certificates make up an estimated 95 percent off all requests, according to the FDA.
According to the FDA, the next phase of the website will include the addition of simple notifications of medical device exports, export permit letters, non-clinical research use certifications and more certificates of product exportability. The website may be expanded in the future to manage the processing and submission of documents beyond those listed above.
The FDA will be providing training sessions for its new Expert Certification and Tracking system. These sessions will be free of charge and do not require preregistration. The First CECATS online training session will be held on December 3rd, 2012, January 8th, 2013 and February 5th, 2013. All sessions will last for an estimated 90 minutes and will start at 2:00 pm.