FDA s Electronic Submissions Gateway (ESG)

Transcription

1 FDA s Electronic Submissions Gateway (ESG) April 19, 2016 Presenter: La Misha Fields, Program Manager FDA ESG Slide 1

2 Agenda What is ESG? ESG Process, Account Types Account Setup and Differences Submission Best Practices ESG Program Milestones and Growth Help Slide 2

3 ESG is: 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. ESG is NOT: A system for tracking the review and approval of a submission. It does not open or review the submissions. Slide 3

4 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 Slide 4

5 Account Setup ~1-2 Weeks 9. Prod Account Ready to Use! 1. Request an Account through ESG Help Desk ~1 Day 2. Obtain a Digital Certificate ~1-2 Weeks ~1 Day 8. Send Test Submission to Preprod Easy Steps for Setting up Your ESG Account with the FDA 3. Submit a Nonrepudiation Letter ~2-3 Days ~1 Day 7. Install JRE/JCE and Configure your Firewall (WT Only) ~1-2 Days 6. Register Account, Account Activation 5. Prepare Load Test Submissions Read User Guide and Tutorials ~1 Day 4. Prepare a Guidance Compliant Test Submission ~1 Day Slide 5

6 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! Slide 6

7 WebTrader Do not need to acquire any software Automatically creates tar/gzip file WebTrader vs. AS2 AS2 Need to acquire/buy AS2 compliant software Tar file is either created manually with an external tar utility or automatically within an application that has tar functionality. No special equipment is required, user can use their own desktop for WT Users will need to send one submission at a time. Submissions can t be automated Low Cost; Minimal technical expertise needed to use WT: Users need to acquire digital certificate and install JRE Suggested for low volume submitters 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. Will need to acquire hardware/required for implementing AS2 system Submissions can be automated More technical expertise/help needed to setup and maintain AS2 system. Suggested for high volume submitters Slide 7

8 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. Slide 8

9 ESG Milestones: ~ 175K Submissions ~ 200 Users ESG Implemented: All Centers ~60K Submissions 2012 ~ 2 M Submissions ~ 15K Users WTHS (Citrix) 2nd Gen Planning ~ 7 M Subs (Proj) ~ 23K Users (Proj) ~ 2 nd Gen Execution 2016 ~ 1.4M Submissions ~ 3 M Submissions ~ 18K Users Collaboration with Industry Slide 9

10 ESG 2 nd 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 2 nd 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 million submissions per year by 2020 Production: Phase I - April 2016 Phase II Later 2016 Slide 10

11 ESG Potential Enhancements Functionality Timely and Informative Acknowledgements Process Account Set-up Process Communications Website User Guide and Other Documents 2-way Communications Slide 11

12 ESG Resources and Contact Information Website: 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: This is used for questions, system and submission related issues, and help in setting up test and production accounts FDA Program Manager: La Misha Fields Phone: Slide 12

13 Thank you! Slide 13

14 HL7 SPL SUBMISSION OPTION April 19, 2016 Varsha Thakar Data Steward Food And Drug Administration Slide 14

15 GUDID HL7 SPL Submission Option Submission of medical device information as HL7 SPL message o 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 Slide 15

16 FDA Electronic Submissions Gateway Two Options for submission o WebTrader o Applicability Statement 2 (AS2) If you choose WebTrader o consider GUDID Web Interface instead of HL7 SPL submission option GUDID does NOT use the esubmitter tool Slide 16

17 Acknowledgements Center = CDRH Submission Type = GUDID Labelers Ack1 Ack2 ESG Ack3 CDRH Slide 17

18 Acknowledgement Types: Ack1 Ack1/Receipt/MDN Slide 18

19 Acknowledgement Types: Ack1, Ack2 Ack1/Receipt/MDN Ack2 Slide 19

20 Acknowledgement Types: Ack3 Slide 20

21 Acknowledgement Type: ACK3 Ack3 <status>failed</status> Slide 21

22 Acknowledgements (Ack) Ack1/2 Issues Ack1 Provide info Ack2 Provide messageid Ack3 Issues Provide coreid Contact appropriate help desk regarding issues prior to retransmitting Slide 22

23 Submission option: HL7 SPL Checklist 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 Slide 23

24 Request and Obtain an ESG Account Gather Data, Generate GUDID HL7 SPL XML Request and obtain a GUDID Test Account PROCESS Time Needed WebTrader 1-2 weeks AS2 2-4 weeks Complete ESG Testing FDA ESG Process Complete GUDID HL7 SPL Testing Submit Test Scenarios for FDA Review Request and Obtain a GUDID Production Account Time Needed 6-8 weeks GUDID Process Submit DI Records to Production GUDID Slide 24

25 Generate GUDID HL7 SPL XML Files Build and generate GUDID HL7 SPL XML files o One file for each DI record o Validate files against the GUDID schema Unparseable error o Most common error during GUDID testing from users o Validating files against the GUDID schema will save you time Slide 25

26 Request and obtain a GUDID Test Account Complete GUDID HL7 SPL Testing GUDID Testing Process 1. Request a GUDID test account 2. Submit XML files with test scenarios Submit Test Scenarios for FDA Review Request and Obtain a GUDID Production Account 3. Submit test results to UDI Helpdesk 4. FDA reviews and provides feedback 5. Submit to Production Submit DI Records to Production GUDID Slide 26

27 ESG and GUDID ESG serves the entire FDA ESG and GUDID have Test and Production areas Submissions sent via ESG Test Account Submissions sent via ESG Production Account Loads to GUDID Test System Loads to GUDID Production System Slide 27

28 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 Slide 28

29 Third-Parties may: Third-Parties Provide software solution/tool to labeler to generate HL7 SPL XML files; labeler sends submission via ESG o 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 labeler o Third-party has the ESG account o Labeler sends a letter of non-repudiation indicating third-party is authorized to submit on their behalf Slide 29

30 Labelers and Third-Party Submitters Labelers who intend to use the HL7 SPL submission option: o Must complete GUDID testing o 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 submissions o Report within the required timeframe o Maintain proper records Slide 30

31 Third-Party Solution Providers May 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 Slide 31

32 GUDID HL7 SPL Pointers Read FDA Guidance on GUDID nandguidance/guidancedocuments/ucm 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 Slide 32

33 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 Slide 33

34 Key Points Submission folder structure must be followed o Top level folder must be uniquely named o 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 Slide 34

35 Records can be submitted as DI Records o Unpublished = DI Record Publish Date is in the future o Published = DI Record Publish Date is today s date or earlier Review your submission via the Web Interface o Login into the GUDID Web Interface o Labeler DUNS number for that DI record should be assigned to you Slide 35

36 Editing HL7 SPL Submissions Submit the entire DI record, i.e., include changed and unchanged attributes o DI record will be over-written with the most recent file o document.id checks for the uniqueness of the GUDID submission o document.setid links all related submissions o 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 Slide 36

37 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 SPL o Any state, any time may edit via Web Interface or HL7 SPL Slide 37

38 Data Quality Before you move to production o Complete adequate internal testing o Verify test records are loaded correctly to GUDID by logging in After you move to production o Continue to monitor, review and correct records during grace period o Review information during Grace Period and make edits as needed o Use export feature to export all records in GUDID as XML files o Remember records go to AccessGUDID after Grace Period Slide 38

39 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 Slide 39

40 Common questions: Please let me know the reason for the below error. Troubleshooting Errors STEP 2. Unable to parse XML STEP 2: UDI SPL submission already exists, submission is duplicate Slide 41

41 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 Slide 42

42 GUDID System Status Scheduled Downtimes o will be posted on o look for GUDID System Status Unscheduled Downtimes o visit for information o if no information, report issue via Help Desk Subscribe to GUDID Alerts: DeviceIdentification/GlobalUDIDatabaseGUDID/default.htm Slide 43

43 Resources - FDA Guidance on GUDID HL7 SPL Implementation Files GUDID Data Elements Reference Table CDRH Learn with GUDID Overview Slide 44

44 Questions Slide 45