HL7 SPL SUBMISSION OPTION - udiconference.com€¦ · Slide 2 Submission of medical device information as HL7 SPL message o One device record data per xml file GUDID HL7 SPL submissions

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HL7 SPL SUBMISSION OPTIONApril 24, 2018

Varsha ThakarTechnical/HL7 Specialist

Food And Drug Administration

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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

GUDID HL7 SPL Submission Option

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FDA Electronic Submissions GatewayESG is a conduit of receiving and delivering submissions to the appropriate center for further processing

Two Options for submissiono WebTradero Applicability Statement 2 (AS2) System to System

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 1(Ack1)

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Acknowledgement 2 (Ack2)

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Acknowledgement 3 (Ack3)

HL7 SPL Implementation Guide 122

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Acknowledgement 3 (Ack3)

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Inquiries

Ack1/2 Issues [email protected] Ack1 – Provide info Ack2 – Provide messageIDContact appropriate help desk regarding issues prior to retransmitting

Ack3 Issues [email protected] Provide coreID

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FDA ESG Process

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

Gather Data, Generate GUDID HL7 SPL XML

Time Needed6-8 weeks

PROCESS

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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

Submissions sent via ESG Production

Account

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GUDID HL7 SPL Pointers Read FDA Guidance and other resources to gather and prepare your GUDID

submissions https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ChangesbetweenUDIProposedandFinalRules/default.htm

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– Do not submit sample message in the HL7 SPL implementation package as a

test submission – it is not validated

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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 Interface

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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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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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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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Web vs HL7 SPL

HL7 SPL67%

Web33%

HL7 SPL Web

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Switching from Web to HL7 SPL OR VICE VERSA

• Only one GUDID account is needed • Keep your account information updated• Testing is required if switching to HL7 SPL submission method• Prior to sending updates in Production, test to ensure you are

able to maintain and update your web created records through SPL

• Make sure your data is synced up with your source system to avoid any issues with updating records via HL7 SPL

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Editing DI RecordsInitial submission

DI Record Status DI Record Edit Status Editing allowed via

Web Unpublished All Fields Editable WebWeb Published In Grace Period WebWeb Published After Grace Period Web or HL7 SPL

HL7 SPL Unpublished All Fields Editable HL7SPL or WebHL7 SPL Published In Grace Period HL7 SPL or WebHL7 SPL Published After Grace Period HL7 SPL or Web

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Thank You