GUDID. (FDA Global UDI Database) Michael Breer Unna, April 2016
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1 (FDA Global UDI Database) Michael Breer Unna, April 2016
2 GUDID timeline September 2014 Class III medical devices (licensed under PHS act) (1 year after publication) must bear a UDI ( ) and the data must be submitted to the GUDID database ( ) September 2015 Implants, etc. must bear a UDI and the data must be (2 years after publication) submitted to the GUDID database ( ) September 2016 Class II medical devives must bear a UDI ( ) and the (3 years after publication) data must be submitted to the GUDID database ( ) September 2018 Class I medical devives must bear a UDI and the (5 years after publication) data must be submitted to the GUDID database ( )
3 Roadmap I. FDA Medical Device classification / registration II. Search/Request D-U-N-S Number III. Request a GUDID Account IV. Request a FDA ESG (AS2) Account Send a Letter of Non-Repudiation to the FDA Obtain a personal digital certificate V. Test the FDA ESG (AS2) Account VI. Refresh & Complete data in NAVISION Refresh item# (regarding ISO conformity) Complete item information regarding HL7 upload VII. Register Medical Devices / Upload data via HL7 SPL xml file
4 FDA Medical Device classifications / registrations Dreve Otoplastik GmbH HEARING AID, AIR CONDUCTION ESD class I SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL EID class I DISINFECTANT, MEDICAL DEVICES LRJ class I etc. Dreve Dentamid GmbH MATERIAL, IMPRESSION TRAY, RESIN EBH class I CROWN AND BRIDGE, TEMPORARY, RESIN EBG class II MATERIAL, IMPRESSION ELW class II etc. Innovation MediTech GmbH HEARING AID, AIR CONDUCTION ESD CLASS I COATING, FILLING MATERIAL, RESIN EBD class II etc.
5 GUDID timeline September 2014 Class III medical devices (licensed under PHS act) (1 year after publication) must bear a UDI ( ) and the data must be submitted to the GUDID database ( ) September 2015 Implants, etc. must bear a UDI and the data must be (2 years after publication) submitted to the GUDID database ( ) September 2016 Class II medical devices must bear a UDI ( ) and the (3 years after publication) data must be submitted to the GUDID database ( ) September 2018 Class I medical devices must bear a UDI and the (5 years after publication) data must be submitted to the GUDID database ( )
6 Search/Request D-U-N-S Number D-U-N-S = Data Universal Numbering System (ein Zahlensystem zur weltweit eindeutigen Identifikation von Unternehmen)
7 Request a GUDID Account GUDID
8 Request a GUDID Account GUDID
9 Fill in the FDA GUDID New Account Request form Send completed form to
10 Indicate GUDID Submission Option Web Interface ESG HL7 Third Party ESG = Electronic Submission Gateway
11 Data upload via GUDID Web Interface Coordinator
12 Data upload via GUDID Web Interface Labeler Data Entry (LDE) DI = Device Identifier
13 Data upload via GUDID Web Interface GMDN vs. FDA PT Code StoneBite (Bite Registration Material) GMDN = FDA PT Code PSGR
14 Data upload via GUDID Web Interface Labeler Data Entry (LDE)
15 Request an AS2 Account:
16 Send a Letter of Non-Repudiation to the FDA.
17 Obtain a personal digital certificate
18 Register the FDA Electonic Submissions Gateway (ESG) AS2 messages over port 4080
19 Download GUDID Device Schema
20 UDI data entry ERP system (Navision)
21 UDI data entry ERP system (Navision)
22 UDI data entry ERP system (Navision)
23 UDI data entry ERP system (Navision)
24 UDI data entry ERP system (Navision)
25 Prepare XML file with ERP system (Navision) XML file must fullfil the HL7 SPL standard
26 About the Unique Device Identifier DI = Device Identifier PI = Production Identifier UDI = Unique Device Identifier
27 HIBC/UDI information GUDID
28 Search at ACCESS GUDID GUDID
29 (FDA Global UDI Database) Michael Breer Dreve ProDiMed GmbH Phone: / michael.breer@dreve.de
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