Zdrowie i gospodarka · 1/22/2013
Electronic Submission Process for Requesting Export Certificates From the Center for Devices and Radiological Health; Availability
The Food and Drug Administration (FDA) is announcing the availability of an electronic submission process for requesting export certificates for products regulated by FDA's Center for Devices and Radiological Health (CDRH). The electronic process will help fulfill both the legislative and application time processing requirements set out by the FDA Export Reform and Enhancement Act of 1996 and the terms of clearance of the Office of Management and Budget approval (OMB control number 0910-0498) of the Form FDA 3613 series. The new eSubmitter process will complement the current paper-based process.