Regulatory Focus™ > News Articles > FDA Unveils Fixes, Enhancements to its eSubmitter System

FDA Unveils Fixes, Enhancements to its eSubmitter System

Posted 08 July 2014 | By Alexander Gaffney, RAC

FDA Unveils Fixes, Enhancements to its eSubmitter System

The US Food and Drug Administration's (FDA) device and biologics review divisions have made several small enhancements and fixes to the eSubmitter system, the agency's electronic system for receiving, filing and tracking product submissions.

The eSubmitter system is currently used by the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), as well as FDA's veterinary and tobacco divisions. Both CDRH and CBER use the system extensively.

CenterSubmission TypeTransmission Method
CBERWhole Blood and Blood Components including Source Plasma BLA and BLS Amendments to applications, and Annual ReportsCD
CBERIndividual Case Safety Reports (ICSR) Adverse Event Reporting for eVAERS Pilot TestingGateway
CBER / CDERGeneric Drug Facility Electronic Self-IdentificationGateway
CDERDrug Adverse Event ReportGateway
CDRHMedical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot ProgramGateway
CDRHAssembler Reports (form 2579)Gateway
CDRHRadiological Health Reports and CorrespondenceGateway or CD
CDRHeCopies (for marketing and study submissions for medical devices)CD
CDRHElectronic Medical Device Reporting (eMDR)(form 3500A)Gateway

On 7 July 2014, FDA announced that it had released one "fix" and three "enhancements" to the eSubmitter software application (Version 2.08.01).

CBER, it said, had released its individual case safety reports (ICSR) to "production" for its Vaccine Adverse Event Reporting System (VAERS) pilot program participants, and had also updated the Biologics License Application (BLA) submissions mailing address and included an updated CBER eSubmitter participant checklist.

CBER recently moved its offices from Rockville, MD to FDA headquarters in Silver Spring, MD, likely necessitating the change.

Similarly, FDA said CDRH had updated the tool with an updated list of product codes, guidance documents and standards.

CDRH had also made a "fix" to the system, FDA explained, which resolved an issue "where standards did not always properly maintain the selected organization and year references."

FDA unveils new changes and fixes to the eSubmitter tool approximately once per month.


FDA eSubmitter Application History


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