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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: esubmitter@fda.hhs.gov.

(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 questionsCBER_eSubmitter_program@fda.hhs.gov or your Consumer Safety Officer 
CBER-ICSR questionsCBERICSRSUBMISSIONS@fda.hhs.gov 
CDRH - eCopiesFor eCopy technical questions, contact cdrhesub@fda.hhs.gov.
For eCopy regulatory questions, contact CDRH-eCopyinfo@fda.hhs.gov.
For eSubmitter questions, contact eSubmitter@fda.hhs.gov.
 
CDRH - eMDR regulatory questionseMDR@fda.hhs.gov 
CDRH - In Vitro Devices and Radiological HealthFor regulatory questions, contact the Division of Industry and Consumer Education (DICE) at dice@cdrh.fda.gov.
For technical questions, contact cdrhesub@fda.hhs.gov.
1-800-638-2041
CTP - Guidances or the Tobacco Control Act questionsTobaccoIndustryQuestions@fda.hhs.gov1-877-CTP-1373
CVM - ONADERegulatory Support
Technical Support