How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and processes more efficient - that’s one reason why the ESG (Electronic Submissions Gateway) solution from FDA is important.

Any time the process of making regulatory submissions can be streamlined, you should take full advantage and that’s what the FDA ESG allows you to do. In essence, you can avoid those thick envelopes of printed documents sent via tracked mail and long wait times all by executing your device submission electronically.

Here’s how it works:

FREE RESOURCE: Click here to get our 5 tips that will help you during the 510(k) submission process.

What is the FDA ESG?

The Electronic Submissions Gateway (ESG) is a solution used by FDA across the entire agency for accepting electronic regulatory submissions. FDA explains the ESG solution here:

The FDA 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. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review.

There are several advantages of using the ESG over outdated methods of submitting paperwork manually:

  1. You don’t have to print off reams of paper to send through the postal mail system.

  2. Your regulatory submission is delivered almost instantaneously to FDA - no waiting for it to arrive by snail mail.

  3. You get an immediate acknowledgment of receipt.

  4. The delivery environment is highly secure - you don’t run the risk of your intellectual property ending up in the wrong hands.

  5. Regulatory submissions get automatically routed to the correct FDA office. In the case of medical devices, this office that would review your submission is the Center for Devices and Radiological Health.

FDA has two methods of submitting electronically; WebTrader and AS2. The agency receives thousands of submissions via those portals on a daily basis. Below are their descriptions of each system:

  • WebTrader (WT): A web portal designed for low volume submitters. WT allows users to login upon creating an account, digitally sign and submit, and view agency responses through a simple web interface.
  • AS2: A system-to-system connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on the submitter's end.

What is the FDA ESG submission process?

Before you get started with the FDA ESG submission process, it’s important to determine whether your submission is eligible. FDA has published a list of all types of electronic submissions supported by the FDA ESG, which has been segmented to medical device-related only in the table below:

 

Center

Submission Type

Notes

CBER






 

510K

Medical Device Premarket Notification

AERS

Adverse Event Reports (AERS)

AERS_Attachments

AERS Attachments

CDISC

Clinical Data Interchange Standards Consortium (CDISC)

EBLA

BLA – Biologics License Application (eBLA format)

EIDE

IDE – Investigational Device Exemption (eIDE format)

EUA

Emergency Use Authorization (EUA)

Lot_Release_Protocol

 

PMA

Premarket Approval Application (PMA)

Promotional_Materials

Promotional Materials

QSUBS

Q-Submissions

SPL_LDD

Structured Product Labeling (SPL) Lot Distribution Database (LDD)

CDRH

Adverse_Events

Adverse Events

Electronic_Submissions

Electronic Submissions

GUDID

Global Unique Device Identification Database (GUDID)

 

How to use the FDA ESG

The first thing you will need to do is set up an account with either WebTrader or AS2. If you are a CRO, US Agent, or consultant, you also need to obtain and submit a Letter of Authorization to the FDA as well as a Letter of Non-Repudiation Agreement. 

Here’s where you can find how to set up those accounts:

Your next step is to follow the FDA ESG submission process, outlined in the diagram below:

FDA-ESG-Submission-Process-Diagram

FDA ESG Submission Process

FDA has outlined the following steps you’ll need to follow during the ESG submission process:

  1. Prepare your submission as per the guidelines for either WT or AS2 (whichever platform you are using). For WebTrader, you need to select center, submission type, submission, signing certificate, and signing certificate password before uploading your submission. For AS2, you must have an encrypted signature, and initiate uploading the submission through the Industry’s AS2.

  2. ESG validates the signature on the submission to ensure it is valid. It then assigns a unique identifier to the submission called the CoreID.

  3. A receipt (called a Message Delivery Notification or 1st Acknowledgement) is sent back to the user.

  4. The submission is unpackaged by the system and restored to its original submission structure. The ESG creates a file or folder with your CoreID name and delivers it to the selected center. That CoreID is used as the file name on all acknowledgments.

  5. “Acknowledgement 2” (Ack2) is generated. If your unpackaging was successful it will let you know and your submission will pass on to the next stage. If the unpackaging was unsuccessful, it will send you an error with Ack2.

  6. The Ack2 is sent back to the user. You can opt in to receive email notifications when any messages are delivered to your WT inbox and should check to make sure the unpacking was successful.

  7. The center will retrieve your submission from the ESG and perform a high-level technical validation. This means checking for things like a valid application number and that the submission is not all in one file. There is a high-level checklist for different centers here.

  8. The Acknowledgement 3 (Ack 3) is generated. Some centers will generate another acknowledgment with validation results. The acknowledgment will either say that the submission has been successfully processed or it will have a Technical Rejection Notification. This will state why the submission was unsuccessful.

  9. The Ack3 is delivered to the user in PDF format.


FDA has compiled a list of some commonly asked questions and answers to help guide you through the ESG submission process with ease.

FREE RESOURCE: Click here to get our 5 tips that will help you during the 510(k) submission process.

Use the FDA ESG to save time & improve Outcome of your device submission

One of the biggest advantages of using the FDA ESG solution is how much time it can save you once you’re ready for your device submission. You can confirm that your submission was received by FDA almost immediately and say goodbye to long wait times that come standard with snail mail.

Of course, you still need to put the time into making a strong case for your device submission; and for that, you need a robust document management system that serves as a single source of truth for all information you’ll need. This is often an area where medical device companies trip up in their submissions. 

Your submission could easily consist of years worth of documents, records, and activities. All of that information must be properly managed and kept in a secure, up-to-date system. The last thing you would want is for all of your hard work and progress to be in vain after using an efficient document management tool that let things fall through the cracks.

One of the surest ways to improve the outcome of your device submission is by using a reliable eQMS to manage all of your documentation. Greenlight Guru is purpose-built for medical device companies and comes fully validated out-of-the-box with dedicated workflows, specifically, Document Management Software along with other workflows for every stage of the product lifecycle.

See how Greenlight Guru can help you streamline the ESG process and improve your device submission outcome by getting your free demo of our QMS software.


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