Integrating Regulatory Submissions with the FDA Electronic Submissions Gateway (ESG)

If your food or pharmaceutical products require approval from the Food and Drug Administration (FDA), you'll need to submit them through the FDA's Electronic Submissions Gateway, commonly known as the FDA ESG. The FDA streamlines their communications through electronic exchange of text and data, providing organizations with two ways to communicate electronically.

Organizations with an extremely low volume of submissions can use the FDA's web portal. But most organizations must exchange approval submissions documents with the agency through AS2, a secure standard for transferring mission-critical documents over the Internet. As a result, implementing FDA-approved AS2 file transfers is a critical requirement to bring nearly any food or pharmaceuticals product through the FDA approval and regulatory process.

Initially championed by Walmart in the 1990s, AS2 is now the default B2B communications standard in retail, manufacturing, logistics and healthcare for sending data between business partners. Though AS2 is an industry standard protocol, the FDA ESG has special and stringent AS2 requirements.

CData Arc makes it easier for you to adhere to these FDA requirements with dedicated, FDA-specific AS2 capabilities.

FDA Requirements for AS2 and How CData Arc Supports Them

In general, AS2 is a data agnostic protocol that knows nothing about the data it's sending and instead focuses on securing that data. AS2 security features include:

• Data encryption, so only trading partners can read the message
• Digital signing to certify the message's authenticity and to prove the sender's identity
• Checksums calculated by the recipient to ensure the payload was transferred correctly
• Message Disposition Notifications (MDNs) that return a receipt with the checksum back to the sender to provide legal proof the message was delivered in its original form

While the FDA takes advantage of these standard features, it also requires additional security measures above and beyond standard AS2 implementations.

File Compression

The FDA requires you to compress files sent via AS2 using the GZip or Tar algorithms. CData Arc offers a Zip Connector for compressing and decompressing files. This connector supports a wide range of file formats, including GZip and Tar. After you configure this connector to create a GZip or Tar file, you simply pass your files through the connector, and it will automatically compress them. The connector works in the opposite direction as well, receiving files in Tar or GZip format and unencrypting them. With CData Arc, you can include this Zip connector in workflows designed to automate the flow of documents to and from the FDA.

Headers

When the standard AS2 protocol performs encryption and signing, it automatically adds specific headers to the message. The FDA adds specific headers on top of the standard AS2 headers. You can see the full list of FDA-specified AS2 header attributes on the FDA AS2 help site.

Most of these are static, the same for every communication. These static headers are easy to employ; you simply add them to your trading partner profile. However, the FDA also incorporates dynamic headers that specify which department within the FDA must receive the message. That means if you're sending a file to a specific FDA center, you need to include the name of that center in the header.

CData Arc enables you to set these headers in an automated fashion using its “Parse FDA Extensions" settings. When you turn on this feature, you can send files to CData Arc with a naming scheme that will dictate which headers should be used. When turning this option on for a file you're sending to the FDA, you should include the FDA center and FDA submission type as the first two parts of the filename separated by periods.

For example the filename: “CDRH.Adverse_Events.myfile.tar.gz" will be sent with the FDA required headers “x-cyclone-metadata-fdacenter:cdrh" and “x-cyclone-metadata-fdasubmissiontype:adverse-events." The resulting filename will be “myfile.tar.gz."

Specific Ports

In most situations where trading partners employ AS2, they do not specify the port types AS2 must use. For example, the default ports for HTTP traffic are 80 for plain text and 443 for SSL/TLS. However, the FDA requires you to listen on Port 5080 and use TLS. If you don't change the port settings, the FDA will not communicate with you. Like most EDI solutions, CData Arc makes it easy to specify the proper port in seconds.

Need for an FDA Profile

Another quirk when communicating with the FDA is that if the FDA does not have a profile set up for you in their system and you attempt to connect with them, their server reply will consist of empty headers, which is not the response your system will expect. If this occurs, you need to talk to the FDA about setting up a profile for you. No EDI/AS2 solution, including CData Arc, can specifically help with this, but it's something you need to be aware of when exchanging documents with the FDA.

FDA ASG Acknowledgments

The FDA has a specific process they follow when you submit an AS2 message, which is different from what you'd use for a standard AS2 message. Like all AS2 messages, the FDA uses the MDN receipt to acknowledge receipt of the message. However, the FDA ESG treats this MDN receipt as the ‘first acknowledgment.'

The FDA ESG system also adds two unique acknowledgments. The second acknowledgment occurs after the FDA unpacks the submission from the Zip file, in a process that takes an average of five minutes.

After performing a high-level technical validation of the message, the FDA generates a third acknowledgment in a process that takes on average one hour.

The actual timeframe you experience will depend on the type of application you're sending and the size of the ESG gateway submission.

File Size

The FDA can process regulatory submissions of up to 100 GB in size. CData Arc makes it easy to send very large files (VLFs). We provide two features that make this process easy. Our Streaming capability improves performance while requiring fewer hardware resources to send VLFs. We also offer an AS2 Restart capability. If you're in the middle of transferring a VLF and your transfer is interrupted, CData Arc allows you to restart the transfer where you left off, rather than having to resend the entire file from the beginning.

In addition, CData Arc undergoes extensive Drummond interoperability testing twice each year to ensure our solution will easily communicate with the FDA. As part of this certification, we undergo the optional Drummond testing for VLFs.

Implementation Support

In addition to providing a full suite of capabilities for managing FDA AS2 complexities, CData Arc offers an experienced professional services team that can help you build the files you need to send to the FDA or to set up your workflow orchestrations.

Get a 30-Day Free Trial and an FDA AS2 Consultation

To learn how CData Arc can simplify your submissions to the FDA, book a consultation with an CData Arc specialist. Just tell us a bit about your FDA submission needs, and we will set up a personalized demonstration for you.

To get started with CData Arc AS2, download a 30-day free trial of CData Arc today or learn more about CData Arc AS2.

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