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  1. FDA eSubmitter

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: [email protected].

(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.

CenterEmailPhone
CBER - OBRR regulatory questions[email protected] or your Consumer Safety Officer 
CBER-ICSR questions[email protected] 
CDRH - eCopiesFor eCopy technical questions, contact [email protected].
For eCopy regulatory questions, contact [email protected].
For eSubmitter questions, contact [email protected].
 
CDRH - eMDR regulatory questions[email protected] 
CDRH - In Vitro Devices and Radiological HealthFor regulatory questions, contact the Division of Industry and Consumer Education (DICE) at [email protected].
For technical questions, contact [email protected].
1-800-638-2041
CTP - Guidances or the Tobacco Control Act questions[email protected]1-877-CTP-1373
CVM - ONADERegulatory Support
Technical Support
 

 

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