The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review by the FDA.
The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDS ESG is a conduit along which transmissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office.
Choosing Your Certificate
IdenTrust can provide identity proofing and issuance of x509 compliant IdenTrust Global Common (IGC) certificates to conduct business electronically with the FDA.
- IGC Medium Assurance certificates can be used with this program.
- Require that the applicant provide proof of identity and proof of organization affiliation.
- For your convenience, IGC certificates can be purchased with or without a storage device (Smart card or USB token) according to your preference.
Simply select BUY NOW and the IdenTrust Certificate Selection Wizard will assist you in choosing a certificate that is accepted by the FDA ESG system and will also meet your business needs.
Visit https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/AboutESG/default.html for more information about the FDA ESG program.
If purchasing a large volume of certificates for your company, please contact Sales@identrust.com as further discounts may apply.
Please note: ONLY THE SUBSCRIBER OF THE CERTIFICATE SHOULD HAVE EXCLUSIVE USE - THE DIGITAL CERTIFICATE IS YOUR FORM OF IDENTIFICATION, SIMILAR TO YOUR PASSPORT OR DRIVERS LICENSE. Under the Certificate Policies governing the issuance and use of certificates offered by IdenTrust, it is our responsibility as an Authorized Certification Authority to revoke the certificate in a case of loss or disclosure of the private key (Password) to anyone other than the subscriber.