Slide 1

FDA’s Electronic Submissions Gateway (ESG)

April 19, 2016

Presenter: La Misha Fields, Program Manager FDA ESG

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Agenda

• What is ESG?• ESG Process, Account Types • Account Setup and Differences• Submission Best Practices• ESG Program Milestones and Growth• Help

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ESG is:

• A system for tracking the review and approval of a submission. • It does not open or review the submissions.

ESG is NOT:

• A conduit of receiving and delivering regulatory submissions to the appropriate center for further processing.

• The central transmission point for sending information electronically to the FDA and automatically routes them to the proper FDA Center or Office.

• Secure and used Agency-wide.

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ESG Process and Account Types

• Web Interface (WebTrader)− Web Interface sends submissions via Hyper Text

Transfer Protocol Secure (HTTPS) through a web browser

− Uses Java applet − Uses Tar functionality− WebTrader Hosted solution: a portal to access

WebTrader• Applicability Statement 2 (AS2) Gateway to Gateway

− Secure HTTP− Requires files to be tarred − Attribute/Header and routing ID information will be

used to route submission− Requires an AS2 compliant gateway software

• All Submissions are signed using PKI certificates

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Account Setup1. Request an Account

through ESG Help Desk 2. Obtain a

Digital Certificate

3. Submit a Non-

repudiation Letter

4. Prepare a Guidance Compliant

Test Submission

5. Prepare Load Test

SubmissionsRead User Guide and Tutorials

6. Register Account,Account

Activation

7. Install JRE/JCE and

Configure your Firewall

(WT Only)

8. Send Test Submission to Preprod

9. Prod Account Ready to

Use!

Easy Steps for Settingup Your ESG

Account with the FDA

~1 Day

~1-2 Weeks

~2-3 Days

~1 Day

~1 Day

~1 Day

~1 Day

~1-2 Days

~1-2 Weeks

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Account Setup – Helpful Tips

• WebTrader accounts should not be shared. Certificates are associated with the accounts that determine the origin of the submission. However, the same account can be used to submit to different centers.

• Recommend having multiple WebTrader accounts if sending large number of submissions.• Each account must send a guidance compliant test submission.• Only one load test is required if the accounts requested are located in same physical location or on

the same physical network as previous accounts established for the company.• Third Party Submitters – register for separate WT account for each of their clients. Letter of

Authorization and Non-repudiation letter required.• A Third Party Submitter can use one AS2 account to submit on behalf of multiple clients• 2-4 weeks for Account Setup, so plan ahead!

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WebTrader vs. AS2WebTrader AS2Do not need to acquire any software Need to acquire/buy AS2 compliant software

Automatically creates tar/gzip file Tar file is either created manually with an external tar utility or automatically within an application that has tar functionality.

Gzip is used after file tarring is complete. It is done either manually using an external utility or automatically within an application that has gzip functionality.

No special equipment is required, user can use their own desktop for WT

Will need to acquire hardware/required for implementing AS2 system

Users will need to send one submission at a time. Submissions can’t be automated

Submissions can be automated

Low Cost; Minimal technical expertise needed to use WT: Users need to acquire digital certificate and install JRE

More technical expertise/help needed to setup and maintain AS2 system.

Suggested for low volume submitters Suggested for high volume submitters

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ESG Submission Best Practices

1. Do not use special characters in file names.a) Do not use /, \, &, #, etc.

2. File names should not contain more than one dot (.) in case of single files. Multi-files/folders should not contain any dots (.) other than in the extension. a) Example: testfile.txt or testfile.tar.gz

3. Encrypt (for AS2 only) files to enhance security.

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ESG Milestones: 2006 - 2016

2006• ESG Implemented: All Centers• ~60K Submissions

• ~ 175K Submissions• ~ 200 Users

2007

20122014 2015

• ~ 2 M Submissions• ~ 15K Users• WTHS (Citrix)• 2nd Gen Planning

• ~ 3 M Submissions• ~ 18K Users• Collaboration with Industry

• ~ 1.4M Submissions

2016

• ~ 7 M Subs (Proj)• ~ 23K Users (Proj)• ~ 2nd Gen Execution

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ESG 2nd Generation

• To ensure that the ESG is stable and can meet current demands and projected future increases in submission loads, FDA intends to address the following areas via the ESG 2nd Generation Modernization project:

– Increase the capacity of the system to handle submission volume increases– High availability; High Throughput for processing submissions and acknowledgements

• Estimated Increase in Submissions:– 7 million submissions projected for 2016– 18-20 million submissions per year by 2020

• Production: Phase I - April 2016– Phase II – Later 2016

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ESG Potential Enhancements

• Functionality• Timely and Informative Acknowledgements

• Process• Account Set-up Process

• Communications• Website• User Guide and Other Documents• 2-way Communications

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ESG Resources and Contact Information•Website: http://www.fda.gov/esg/

–Account Information–System Requirements–User Guide and Tutorials–Digital Signatures and Certificates–System Status, Planned Outages, Metrics and Help Desk–Links to submission guidelines

•Account Setup: ESGHelpDesk@fda.hhs.gov–This email is used for questions, system and submission related issues, and help in setting up test and production accounts

•FDA Program Manager: La Misha Fields–Email: lamisha.fields@fda.hhs.gov–Phone: 240-402-5192

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Thank you!

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HL7 SPL SUBMISSION OPTIONApril 19, 2016

Varsha ThakarData Steward

Food And Drug Administration

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GUDID HL7 SPL Submission Option Submission of medical device information as HL7 SPL

messageo One device record data per xml file

GUDID HL7 SPL submissions are submitted via the FDA ESG

Testing required prior to submitting data to Production GUDID

Ideal for labelers with large volume of submissions

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FDA Electronic Submissions Gateway Two Options for submission

o WebTradero Applicability Statement 2 (AS2)

If you choose WebTradero consider GUDID Web Interface instead of HL7 SPL submission option

GUDID does NOT use the eSubmitter tool

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Acknowledgements

LabelersESG

CDRH

Ack1Ack2

Ack3

Center = CDRHSubmission Type = GUDID

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Acknowledgement Types: Ack1

Ack1/Receipt/MDN

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Acknowledgement Types: Ack1, Ack2Ack1/Receipt/MDN

Ack2

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Acknowledgement Types: Ack3

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Acknowledgement Type: ACK3

Ack3

<status>Failed</status>

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Acknowledgements (Ack)

Ack3 Issues gudidsupport@fda.hhs.gov Provide coreID

Ack1/2 Issues esghelpdesk@fda.hhs.gov Ack1 – Provide info Ack2 – Provide messageID

Contact appropriate help desk regarding issues prior to retransmitting

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Submission option: HL7 SPLChecklist for submitting in Production environment

Obtain an ESG Test Account (contact FDA ESG Helpdesk) Obtain a GUDID Test Account (contact FDA UDI Helpdesk) Complete GUDID HL7 SPL testing Submit test scenarios to FDA UDI Helpdesk

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PROCESSRequest and

Obtain an ESG Account

Complete ESG Testing

Request and obtain a GUDID Test

Account

Complete GUDID HL7 SPL Testing

Submit Test Scenarios for FDA

Review

Request and Obtain a GUDID Production

Account

Submit DI Records to Production GUDID

FDA ESG Process

GUDID ProcessTime NeededWebTrader 1-2 weeksAS2 – 2-4 weeks

Gather Data, Generate GUDID HL7 SPL XML

Time Needed6-8 weeks

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Generate GUDID HL7 SPL XML Files

Build and generate GUDID HL7 SPL XML fileso One file for each DI recordo Validate files against the GUDID schema

Unparseable erroro Most common error during GUDID testing from userso Validating files against the GUDID schema will save you time

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GUDID Testing Process1. Request a GUDID test account

2. Submit XML files with test scenarios

3. Submit test results to UDI Helpdesk

4. FDA reviews and provides feedback

5. Submit to Production

Request and obtain a GUDID Test

Account

Complete GUDID HL7 SPL Testing

Submit Test Scenarios for FDA

Review

Request and Obtain a GUDID

Production Account

Submit DI Records to Production

GUDID

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ESG and GUDID ESG serves the entire FDA ESG and GUDID have Test and Production areas

Submissions sent via ESG Test Account

Loads to GUDID Test System

Submissions sent via ESG Production

Account

Loads to GUDID Production System

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Using Third-Party Submitters Provide Third-Party information during GUDID account request

o If third-party is not associated to labeler’s GUDID account, submission from third-party will be rejected

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Third-PartiesThird-Parties may:

Provide software solution/tool to labeler to generate HL7 SPL XML files; labeler sends submission via ESGo Labeler obtains ESG account

Provide end-to-end solution: use labeler data to generate GUDID HL7 SPL XML files AND send submissions via ESG on behalf of labelero Third-party has the ESG accounto Labeler sends a letter of non-repudiation indicating third-party is

authorized to submit on their behalf

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Labelers and Third-Party Submitters Labelers who intend to use the HL7 SPL submission option:

o Must complete GUDID testingo Testing required even if using a third-party submitter

Labelers are responsible for fulfilling GUDID submission requirements: o Ensure submissions are received and processed by FDA.o Login to GUDID and review your submissionso Report within the required timeframeo Maintain proper records

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Third-Party Solution ProvidersMay test GUDID HL7 SPL submission solution independently of Labelers

Request a GUDID test Account: indicate it is for HL7 SPL testing Dummy data for certain required attributes provided for testing

purposes ONLY, upon request GUDID Web Interface and Production Accounts NOT provided

Must complete GUDID HL7 SPL testing with each labeler Labelers must establish their own separate test GUDID account

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GUDID HL7 SPL Pointers Read FDA Guidance on GUDID

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

Allow adequate time for testing – ESG and GUDID

GUDID testing completion criteria is the bare minimum– Do thorough internal testing to ensure scenarios appropriate for

your products are accounted for

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GUDID HL7 SPL Pointers

Do not submit sample message in the HL7 SPL implementation package as a test submission – it is not validated

Specify• Center = CDRH• Submission Type = GUDID

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Key Points Submission folder structure must be followed

o Top level folder must be uniquely namedo Lower level folder must always be named “spl”; only one “spl” folder o GUDID HL7 SPL xml submission file must be named “submission.xml”o Do not include any other files in the “spl” folder

Only one submission (one DI record) in each folder structure

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DI Records Records can be submitted as

o Unpublished = DI Record Publish Date is in the futureo Published = DI Record Publish Date is today’s date or earlier

Review your submission via the Web Interfaceo Login into the GUDID Web Interfaceo Labeler DUNS number for that DI record should be assigned to you

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Editing HL7 SPL Submissions Submit the entire DI record, i.e., include changed and unchanged

attributeso DI record will be over-written with the most recent fileo document.id – checks for the uniqueness of the GUDID submissiono document.setID – links all related submissionso document.versionNumber – tracks versions; increment by 1 for each edit, even

for failed submissions- First time submission, versionNumber = 1, Ack3 = Fail- Increment versionNumber = 2

o assign a new document.id, keep the same setID and increment the versionNumber before resubmitting

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Editing DI Records DI Records submitted using Web Interface

o Draft, Unpublished, Published during Grace Period must edit via Web Interface

o Published and past Grace Period may edit via Web Interface or HL7 SPL

DI Records submitted using HL7 SPLo Any state, any timemay edit via Web Interface or HL7 SPL

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Data Quality Before you move to production

o Complete adequate internal testingo Verify test records are loaded correctly to GUDID by logging in

After you move to productiono Continue to monitor, review and correct records during grace

periodo Review information during Grace Period and make edits as neededo Use “export” feature to export all records in GUDID as XML fileso Remember records go to AccessGUDID after Grace Period

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Submitting Batches in Production Start submissions in small batches and slowly ramp up

Limit submissions to no more than 500 at one time

If you do not receive Acknowledgements, do not automatically “resend”, contact us first

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Troubleshooting ErrorsCommon questions:

Please let me know the reason for the below error.

STEP 2. Unable to parse XML

STEP 2: UDI SPL submission already exists, submission is duplicate

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HelpDesk Do not contact multiple helpdesks or create multiple cases to report the

same issue Please wait for 48 hours before reporting any ACK3 delays to the FDA

UDI Helpdesk Do not send submissions prior to obtaining a GUDID account – your

submissions will be rejected with a failed Ack3 message Before submitting test scenarios – review them and ensure that all the

edits are accurately reflected in GUDID

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GUDID System Status Scheduled Downtimes

o will be posted on www.fda.gov/udio look for GUDID System Status

Unscheduled Downtimeso visit www.fda.gov/udi for informationo if no information, report issue via Help Desk

Subscribe to GUDID Email Alerts: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm

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Resources - www.fda.gov/udiFDA Guidance on GUDID

HL7 SPL Implementation Files

GUDID Data Elements Reference Table

CDRH Learn with GUDID Overview

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Questions