For Industry

Contact eSubmitter

For your convenience, we have set up an email account so we can answer your questions about the eSubmitter software. Please send your questions or comments related to the eSubmitter Application to the eSubmitter Technical Support Team at:

(If you are looking to submit a general question or comment please find the appropriate email address listed at FDA Basics for Industry: Submit Questions and Comments.)

Send questions about FDA regulations or template specific questions to the specific program office listed below. Please be sure to include your name, company name and contact information in the email.

Center Email Phone
CBER - OBRR regulatory questions or your Consumer Safety Officer  
CBER-ICSR questions  
CDER - Drug Registration and Listing questions  
CDER - Adverse Event Reporting questions   
CDER - Generic Drug Facility Electronic Self-Identification  
CDRH - eCopies For eCopy technical questions, contact
For eCopy regulatory questions, contact
For eSubmitter questions, contact
CDRH - eMDR regulatory questions  
CDRH - ISO 13485 questions  
CDRH - In Vitro Devices and Radiological Health For regulatory questions, contact the Division of Industry and Consumer Education (DICE) at
For technical questions, contact
CTP - Guidances or the Tobacco Control Act questions 1-877-CTP-1373
CVM - ONADE Regulatory Support
Technical Support

Page Last Updated: 07/23/2015
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