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U.S. Department of Health and Human Services

For Industry

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Contact Us

We welcome your comments. For your convenience, we have set up an email account so we can answer your questions about this software. Please email your questions or comments to the eSubmitter Technical Support Team at: esubmitter@fda.hhs.gov.

Send questions about FDA regulations 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 - OBE regulatory questionsCBER_eSubmitter_program@fda.hhs.gov 
CDER - Drug Registration and Listing questionsedrls@fda.hhs.gov 
CDER - Adverse Event Reporting questionsFAERSESUB@fda.hhs.gov  
CDER - Generic Drug Facility Electronic Self-IdentificationCDEReFacility@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 - ISO 13485 questionsISO13485@fda.hhs.gov 
CDRH - In Vitro Devices and Radiological HealthFor regulatory questions, contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at dsmica@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