Learn about the Electronic Submissions Gateway (ESG) of US FDA, and key points to consider when planning your regulatory submission process
Janaka Bandara
Published: 14 Feb 2023
Making regulatory submissions to U.S. Food and Drug Administration (FDA), is a highly standardized process. In 2006, FDA established their own dedicated recipient entity, the Electronic Submissions Gateway (ESG), to serve submitters of different scales.
Quoting FDA, the ESG “is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols”.
At a high level, FDA ESG operates like a post office:
ESG uses a special correlation ID (CoreID) on its sequence of acknowledgements, to associate them with the original submissions.
ACK2 contains the mapping details: namely the original message reference (e.g. AS2 Message-ID header value from the client submission), against the ESG-assigned CoreID. Subsequent ACKs will only contain the CoreID (as the name of the transmitted file), and the client is responsible of mapping them back to the original submission trail, based on the mapping delivered in the original ACK2.
FDA ESG allows two modes of submission:
Both modes involve secure communications with encryption and digital signatures; however, AS2 is preferred by most organizations because it:
To decide on what solution to choose, following questionnaire may be helpful:
FDA has detailed documentation on setting up each submission mechanism:
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