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.
| Center | Phone | |
| CBER - OBRR regulatory questions | CBER_eSubmitter_program@fda.hhs.gov or your Consumer Safety Officer | |
| CBER - OBE regulatory questions | CBER_eSubmitter_program@fda.hhs.gov | |
| CDER - Drug Registration and Listing questions | edrls@fda.hhs.gov | |
| CDER - Adverse Event Reporting questions | 1-800-FDA-1088 | |
| CDER - Generic Drug Facility Electronic Self-Identification | CDEReFacility@fda.hhs.gov | |
| CDRH - eCopies | For 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 questions | eMDR@fda.hhs.gov | |
| CDRH - ISO 13485 questions | ISO13485@fda.hhs.gov | |
| CDRH - In Vitro Devices and Radiological Health | For 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 questions | TobaccoIndustryQuestions@fda.hhs.gov | 1-877-CTP-1373 |
| CVM - ONADE | Regulatory Support Technical Support |
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