FDA GUDID User Manual
Contents
1. a Pete Tewch Manage Accounts Enim rfcemaier 5 Chick Fitter Resuts zhan mi babae Gee F Manage Accounts Lan Himi Fira Hari hierar Emaik Statue ccom Type DUNS F Cxganiration Lobster Gata Emir 7 View 10 AEE a EE DER an AGEI Us ertarree Eii r Acteurl Tape hap ie Seas Aled Feil Labeler Data Entry Beaz Alen Aia Enabled Ariaid 4 eon i asees me og Labeli Guna Entry rane ese Enatied Acteated y Fant Pisces 11 pee vr Click on the username link to see account details Distributed by www regulatorydoctor com for informational purposes only 13 Account Details for Suggs Terrell Erodes E adai Rael Papeord reer noms Arenum Type Loteler Cite Eniri hint eirs First Mama Email Piai igs Tarredl feet sagged hha gov a bt tb LS Bin its in ie Ceganizatice MAG A Ceqantzatice Hami EIET Biat Aien Harralton ire Address 1 Addreaa 7 city Slat Pace a nE Pemai Coume 1 Prepere Ploy Ste 209 W ATY LSA L ski Ati Cui A I vip Toco arr xe Benz Allen Hendin inc 1 Preparan Picy Ste 200 Flow kratk tL at re ie UA Sae Rest Cancel You can edit the account details and then click Save Account Status and Mode An account can have an enabled or disabled status An enabled account is able to login in to GUDID A disabled account cannot login to GUDID and must have the account re enabled by a coordinator Re enabling the account automatically chang2. FID JAN Food and Drug Administration yer for ce Os CDp H 2 Center for Devices and Radiological Health ey 30 Global Unique Device Identification Database GUDID User Manual Version 1 0 Date April 24 2014 Distributed by www regulatorydoctor com for informational purposes only Table of Contents WF MU OCC Oise tacassen es ceanetsearcacnnedaet ntre toneneagessobes E 3 2 How to obtain a GUDID ACCOUDL ceesnnnnnnneeeeeeeeeeeeeeeeeceeeeeceeeceeecaceeeesececesaceneaeaeeeseneeeeeaeeeeneeaaanas 4 SAH TN UE A N escent niece ce cg sles nee gc tien AN A NE E A coon ean A E 4 3 Browser Compati DINIY sespseriereiiie einun Ei a EE EEEE E EER 4 Bn Cmm TUNC ONS eea E EE 5 P OOK CIAL OM cee ties ccisateesieaia daietes E E EE 11 34 Labeler Data Eotry LDE S68 sceri 15 AT ke D EAD ear E N ceases sueeeeeaee lt 25 4 2 GUDID Sample Record of an Unpublished Record 1 0 0 0 eee 26 4 2 1 Creating a New DIL IR CC O10 issciccaiesvnsevndudeueinnstescvsausacvinesCaderndateueinnstedvnssiaesinsatacesxdlewsiarateseaiannces 26 2 Distributed by www regulatorydoctor com for informational purposes only 1 Introduction The Food and Drug Administration FDA is responsible for protecting the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products medical devices the nation s food supply cosmetics dietary supplements and products that give off radiation and f
3. Issuing Agency must be selected Enter Primary DI Number amp Device Count These are required data elements hence entries must be made Enter Unit of Use DI Number if applicable to your record Select the appropriate Labeler DUNS Number from the drop down list This is a required data element hence a Labeler DUNS Number must be selected 26 Distributed by www regulatorydoctor com for informational purposes only The Company Name and Company Physical Address is system populated through D amp B Database Enter Brand Name and Version or Model Number These are required fields hence entries must be made Enter Catalog Number and Device Description Note that not all fields in GUDID are required Fields that are marked with are required data fields for GUDID Rest of the information is required if it is available on the medical device label Publish date could be set in future DI Record Pub Poll ad yyyy Commercial Distribution End Date mm dd yyyy Commercial Distribution Status B El i Alternative and Additional Identifiers Direct Marking DM Secondary DI F z x Add Secondary DI M Device Subject to Direct Marking DM but Exempt Issuing Agenc Secondary DI Number Action M DM DI Different from Primary DI ote is z DM DI Number No secondary device identifiers currently defined Package DI GP add Package DI Package DI Humber Quantity per Package Contains DI Package Package Type Packag
4. Data Entry LDE User Overview of Functionality for Labeler Data Entry LDE User Role Labeler Data Entry User Homepage 15 Distributed by www regulatorydoctor com for informational purposes only Welcome Terrell Suggs QR Sairis prea es re beri teed ed eed ee eee a fe de eee Tea eee eee MAMATE Dil Search DI Records F I SEARCH DI Search DI allows a LDE user to search for public DI records Note This link is temporarily disabled and will be enabled when Public Search is made available Find FDA PT Code FIND FDA PT CODE DA preferred term code Find FDA PT Code allows an LDE to search for a GMDN Preferred Term of GMDN Definition and retrieve the FDA assigned Preferred Term Code Manage DI Records drop down Manage DI Submitted DI 16 Draft DI Create New DI Distributed by www regulatorydoctor com for informational purposes only Manage DI allows an LDE User to create and manage DI records for their assigned Labeler DUNS numbers The Manage DI drop down allows an LDE User to navigate to Submitted DI Draft DI or Create NewDI functionality Manage DI Records MANAGE DI The Manage DI icon will navigate the user to their Submitted DI records This includes Published and Unpublished DI Records Draft DI Records DRAFT DI The Draft DI icon will navigate the user to their Draft DI records The Draft DI records can only be viewed by the user that created the record See exa
5. Device Nomenclature GMDN Preferred Term Name or GMDN Definition to retrieve the FDA Preferred Term PT Code Global Medical Device Nomenclature GMDN is a system of internationally agreed descriptors used to identify medical device products and is managed by GMDN Agency Visit http www gmdnagency com default aspx Distributed by www regulatorydoctor com for informational purposes only After entering GMDN Preferred Term Name or Definition text and clicking the search button the search results will display a list of active FDA PT Code associated GMDN Term and GMDN Definition from the database related to the keywords provided in the search text field For example asearch for the GMDN Term defibrillator will yield the results as shown Ray Rice COORDINATOR D Home Search Manage Accounts v Find FDA Preferred Term Code View 25 Bi 25 63 records 1 3 page DESINIT FDA PT Code Term Definition A cart designed to store transport devices and supplies used in emergency resuscitation procedures This trolley cart typically consists of a shelf drawer cabinet like structure on wheels that contains a defibrillator XRVN Resuscitation trolley equipped electrocardiograph ECG monitor pulmonary resuscitator backboard for external cardiac compression surgical supplies drugs and various other instruments and accessories necessary to initiate cardiopulmonary resuscitation CPR A conduct
6. Discontinue Date if applicable Enter Package Status Action button allow users to edit the information Customer Contact GP add Customer Contact Customer Contact Phone Customer Contact Email Action XXX DX XX 2x xXx DKK XX L gt x For entering Customer Contact information click on Add Customer Contact Enter Customer Contact Phone If there is no phone number please enter 999 999 999 When checkboxes Enter Customer Contact Email If there is no email please enter xxx xx xx are not Action allows user to make changes to Customer contact checked value is set to No 28 Distributed by www regulatorydoctor com for informational purposes only Device Status Human Cell Tissue or Cellular or Tissue Based Product HCT P Premarket C Device Exempt from Premarket Submission GP Add Premarket Submission Number Product Code Product Code Hame Action Lat Action bod FDA Premarket Submission Supplement Jumber Humber FDA Listing FDA Listing Humber Action Code Hame Definition Enter Premarket Submission Number and Supplement number which are used to obtain approval for the version or model number of the device for which this record is being created Figure 4 Screenshot of GUDID interface In Device Status section Check 1f the device is Human Cell Tissue or Cellular or Tissue Based Product HCT P Check if the device is a Kit Check if t
7. Draft DI Records You can choose to remove a Draft DI record permanent by clicking the Remove button To narrow the list of results you can filter by DI number Company Name Brand Name and Version or Model Number The results of the filter appear in the table at the bottom of the page 22 Distributed by www regulatorydoctor com for informational purposes only Home Seach Manage Ca Manage Drafts CM Hural Company Kame View pj F ad recde TFN pee CH Shorr ae fo Coenpary Mame ee Arimo U page Aprea i Brand Hame Versica of Model Hamber E EL Binst Haes Wetinif de Mendel Mamita Puge Dne FRamov z roo A aaa 0 55 Ph lt a on rt Click a DI number to open the DI Record Detail You can Edit Save Draft Delete Draft Review or Cancel The Save Draft button will save the draft as long as the DI record contains a primary issuing agency and primary DI number The Delete Draft button will permanently remove the draft The Review button will perform validation on the DI record and if it passes the record can be submitted The Cancel button will change all changes and return the DI record back to its last saved version Horma Seth Klange H Device Identifier DI Record Details for Draft Record Device information Device Kientifier Dl Information leeaing Agency Primary Mummies C48 Meg Pea Pa gs bee Ladecler HUNS Company Hace Bumbi ATIR Brand Hema Divis
8. eripi Commercial Heributian D Recond Pubtish Date mantddiyyyy PAEPAE Bovice Count 4 Company Physa Address Version or Hodel Humber Commercial Dminibution End Date immedi yr ere eae a Umit cd Use H ieee JAGTAGLBET INS D Cotakeg Number ZHU Cammi Dieiibution Shane 25 Distributed by www regulatorydoctor com for informational purposes only Copy Existing DI Record Only Published and Unpublished DI records can be copied To copy a DI record go to the Manage DI page and click on the DI number you would like to copy Click Copy to create a copy of the DI record The copied data displays on the DI Record Details for New Record form Device Identifier DI Record Details for Published Record Poole he Tey Hor Device Infonmaton Cevice JdeotHiec 0 inicemetion Eseing Agency Primary Ol heiter Derre Coun inde od Use Ci Preis aso recip SE 4S hd Squire l Leics DURS Company Name Company Gye dapent INS Dm FINALAK gt rE g81705a1 Bren Hane imi LiNE mm mm im j Caisg Aigner I Note to system users When working with a copied DI record whether published or unpublished please ensure to change all data fields to accurately capture the device information in the database 24 Distributed by www regulatorydoctor com for informational purposes only 4 1 Package DI Label Not all fields in GUDID are required to be on the label This example is for illustr
9. forthe GMDN Preferred Term Name External defibrillator electrode pad The results will show the FDA PT Code the Term GMDN Preferred Term Name and the Definition GMDN Definition providing details of the active GMDN code Note to system users The GMDN is not a codeset owned by FDA For any questions regarding GMDN Codes or how to access a full list of these terms please contact the GMDN Agency at https www qmdnaqency com 10 Distributed by www regulatorydoctor com for informational purposes only 3 3 Coordinator Overview of Functions available for a Coordinator Role Coordinator Home Page Home Search v Manage Accounts v fa hii Welcome Ray Rice Search function is temporarily disabled and will be enabled at a future date when the database is populated SEARCH DI MANAGE ACCOUNTS Search DI Search DI allows a Coordinator to search for public DI records Note This functionality is temporarily disabled and will be enabled when Public Search is made available Find FDA PT Code a _ Fino FDA PT CODE FDA PT Code allows a Coordinator to search for a GMDN Preferred DA preferred term code Term or GMDN Definition and retrieve the FDA assigned Preferred Term Code See FDA PT Code The FDA PT Code is mapped to the GMDN code 11 Distributed by www regulatorydoctor com for informational purposes only Manage Accounts MANAGE ACCOUNTS Manage Accounts allows a Coordinator to view and manage L
10. you understand and consent to the following agree to System User Agreement Anyone who makes a materially false fictitious or fraudulent statement to the U S Government is subject to criminal penalties See Title 18 U S C 1001 Any information system usage may be monitored recorded and subject to audit Anyone using this Retrieve Username required fields Search function is temporarily disabled and will be enabled at a future date when the database is populated Email Po Send My Username Cancel If you forget your password click Password Enter username and email associated with the password Click Send My Password Distributed by www regulatorydoctor com for informational purposes only Search Retrieve Password required fields Search function is temporarily disabled and will be enabled at a future date when the database is populated Username Email Send My Password Cancel You will receive two emails 1 Password reset notification 2 Temporary password Login to the GUDID with the temporary password and your username The system will then ask you to change your password User Profile for 7 eped kii x You must change your password User Details Change Password When changing your password it must be 8 32 characters with at least one upper case letter one lower case letter one number and one of the following special characters T 0 F T 0 0 P Username C
11. MRI safety information does the labeling contain Prescription Use Rx Labeling does not contain MRI Safety Information M Over the Counter OTC Clinically Relevant Size GP Add Size Size Type Text Action K Ja Ll Length amp Millimeter Length 2 25 Millimeter Figure 5 Screenshot of GUDID interface In Device Characteristics section Select the appropriate value from the drop down list for whether the device is intended for single use This is a required field and hence a value must be selected Enter the Production Identifiers on the Label and make appropriate selections from the drop down list for Lot or Batch number Manufacturing Date Serial Number Expiration Date and Donation Identification Number All these fields are required and hence a value must be selected 30 Distributed by www regulatorydoctor com for informational purposes only Select a value from the drop down list for Device required to be labeled as containing natural rubber latex or dry natural rubber 21CFR 801 437 This is a required field and hence a value must be selected Check if the Device is labeled as Not made with natural rubber latex Check if the device requires Prescription Use Rx Check if the device is available Over the Counter Select a value from the drop down list as an answer for the question What MRI safety information does the labeling contain This is a required field and hence a value must
12. a attached to this network or to a computer on this network Password must be 8 32 characters with at least one upper case letter one lower case letter one number and one of the following special characters a ee al By using this information system you understand and consent to the following Any unauthorized or improper usage of this information system is prohibited and may result in disciplinary action as well as civil and criminal penalties Anyone who makes a materially false fictitious or fraudulent statement to the U S Government is agree to System User Agreement A k subject to criminal penalties See Title 18 U S C 1001 Login x Any information system usage may be monitored recorded and subject to audit Anyone using this information system expressly consents to monitoring and is advised that if such monitoring reveals possible criminal activity system personnel may provide the evidence of such monitoring to law enforcement officials You have no reasonable expectation of privacy regarding any communications or data transiting or stored on this information system At any time and for any lawful government purpose the government may monitor intercept and search and seize any communication or data transiting or stored on this information system Any communications or data transiting or stored in this information system may be disclosed or used for any lawful government purpose Username and Password To
13. abeler Data for their assigned Labeler DUNS Number Manage Accounts View Accounts Create New Account The drop down menu of Manage Accounts allows a Coordinator to navigate to View Accounts or Create New Account Access the Database To begin Login into GUDID as a Coordinator see Subsection 2 2 for detailed information The home is displayed at login see figure below Click the Manage Accounts button or select the Manage Accounts from the menu bar Note A username and temporary password will be sent to the LDE user when the Coordinator creates an account Home Search v Manage Accounts v bav Rica o Welcome Ray Ric View Accounts Search function is tempor Create New Account re date when tj database is populated a4 44m hy search pub SEARCH DI MANAGE ACCOUNTS C FIND FDAPT CODE i A a um m eee m PP mm AN content am Manage and create coordinators Ll find FDA preterred term code 12 Distributed by www regulatorydoctor com for informational purposes only Manage Accounts Upon entry Manage Accounts will display all accounts available for you in a table You can filter for a specific account by typing in any of the fields provided Last Name First Name User Name Email Status Mode etc Enter information into the field you desire to filter by and then click Filter The results of the filter appear in the table at the bottom of the page a age ae ET A EE ey _ iy a _
14. ative purpose only CompuHyper GlobalMed Ultra Implantable dical Ve p C 2 25 mm x 8 mmm Production identifier Expiration Date Catalog Number EAT 123456 P Catalog Number 120450 ee Production Identifier Lot Number Storage and i Aa TO Handling i i TEMPERATURE For Single Use Labeler Name amp Labeler Physical Address ustomer Contact Unique Device Identifier DI amp PI Information Figure 1 Fictitious Medical Device label Distributed by www regulatorydoctor com for informational purposes only 25 4 2 GUDID Sample Record of an Unpublished Record 4 2 1 Creating a New DI Record Global Unique Device Identification Database IK Home Search Manage DI LABELER Device Identifier DI Record Details for New Record Printer Friendly Device Information Device Identifier DI Information Issuin ve Primary Dl Number Device Count Unit of Use DI Number Cees eateries D je Labeler DUNS Company Name Company Physical Address Nu s ntion ms s Version or Model Number Catalog Number Device De Figure 2 Screenshot of GUDID interface The fictitious medical device label in Figure 1 is used as an example to create this new DI record in GUDID To enter Device Identifier DI information related to your medical device Select your Issuing Agency from the drop down list This is a required data element hence an
15. be selected For adding clinically relevant Click on the Add size button Action button allow users edit the information Storage and Handling GP add Storage and Handling Storage and Handling Action Sterilization Device Packaged as Sterile Requires Sterilization Prior to Use No GP add Sterilization Method Sterilization Method Action No sterilization method currently defined Activated Unpublished View History Printer Friendly Figure 6 Screenshot of GUDID interface For entering Storage and Handling information Click on the Add Storage and Handling button Action button allow users edit the information Enter information related to Sterilization Enter Select the appropriate entry from the drop down list for Device Packaged as Sterile This is a required element hence a value must be selected 31 Distributed by www regulatorydoctor com for informational purposes only Enter Select the appropriate entry from the drop down list for Requires Sterilization Prior to Use This is a required element hence a value must be selected Enter a sterilization Method by clicking on the Add Sterilization Method Action button allow users to edit the information Currently the DI record is in an unpublished state Review checks whether the record has met all the system and business rules Cancel allows users to exit the screen without saving the record Note to system users Unpublished record
16. by www regulatorydoctor com for informational purposes only Edit Existing DI Record Open a published DI record from the list You will see on the top left of the screen that the DI record is Published Click Edit at top or bottom right the page Update the information as you desire After editing click Review and Submit to save changes Open an unpublished DI record from the list You will see on the top left of screen that the DI record is Unpublished Click Edit at the top or bottom of the page Change the form as needed After editing click Review and Submit to save changes Note that the Unpublished DI allows you to edit all the fields without limitation Heres Samgch Marage Di Device Identifier DI Record Details for Published Record i Pushed View or ccgry the oxieding MH Crevice Information Click View Hitoy for O record history Device dentfier DH lafonmation Click Edie to alter Di hauling Agency Primary Ef Muenbor Devices Count tnit of Lise CM Humbar Labeler DUNS Company ame Company Pireka Address uimisen Erand Marte Woriica w Mie Humber Catshy Humbin Device Description Commercial Disiributign Di Record Publith Date jmmiddiyyyy Commercial Disiributton Ead Daie mmddyy Commoarcial Oienitutlon Status Manage and Edit Draft DI Record To manage draft DI records click the Draft DI record button or Draft DI record link under the Manage DI dropdown You will be returned with all of the
17. com for informational purposes only Open an unpublished DI record from the Manage Device list You will see on the top left of the Device Identifier Details page that the DI record is Unpublished Note to system users The device manufacturer cannot change a DI record status from Published to Unpublished without intervention from FDA staff Distributed by www regulatorydoctor com for informational purposes only 19 Create New DI Record When you click the New DI button the DI Record Details screen will open up Complete the DI Record Details for a new DI record Click Save Draft if you have not completed the form you must include at least the Primary Issuing Agency and Primary DI Number to save as draft Draft DI records will appear on the Drafts DI screen for future editing system will purge Draft DI records after 180 days from the last modified date Please refer to Sample DI Record for examples data entry use cases To submit a DI record you must provide a valid GMDN code or an FDA Preferred Term Code PT Code For assistance in understanding the GMDN description and with GMDN code assignment we refer you to GMDN Agency To look up a valid FDA PT Code use the Find FDA PT Code feature as shown in FDA PT Code Click Review after you have completed the DI record The system runs business rules on entered information to ensure all entries are valid and all required fields have values If the DI record has errors the user must c
18. e Discontinue Date Package Status Action No package device identifiers currently defined Figure 3 Screenshot of GUDID Interface As you scroll down in the New Record window you will be able to enter Commercial distribution information of the device Select or enter DI Record Publish date in mm dd yyyy format This is a required data element hence DI Publish Record Date must be selected Select or enter Commercial Distribution End Date in mm dd yyyy format Commercial distribution status field is system populated based on your entries in DI Record Publish date and Commercial Distribution End Date In the Alternative and Additional Identifiers section enter the following Direct Marking DM information if it applicable to your medical device for which the record is being created 24 Distributed by www regulatorydoctor com for informational purposes only Check the Device Subject to Direct Marking DM but Exempt Check DM DI Different from Primary DI If the DM DI Different from Primary DI is checked then enter the DM DI Number For entering Secondary DI number Click on the Add Secondary DI Select the Issuing Agency from the drop down list Enter Secondary DI Number Action allows user to make changes to Secondary DI For entering multiple levels of packaging Click on Add Package DI Enter Package DI Number Enter Quantity per Package Enter Contains DI Package Enter Package Type Enter Package
19. es the user s password to a temporary password notifies the user of the change via an automated email The temporary password must be changed before GUDID access 1s restored An account can also be inactivated or deactivated mode The default for each account 1s activated mode If an account is set to deactivated then the account cannot access GUDID and that account cannot be recovered On the Manage Accounts and Account Details screen you can change the status and mode by clicking Enabled Disabled and Activated You can also reset the user s password which will cause the user 14 Distributed by www regulatorydoctor com for informational purposes only to receive a temporary password via email Create New Account To create a new account click Add New Account on the Manage Accounts page On the Create New Account page enter the required information to create a new account When complete click Save hire Emm Manage Accomis Create New Account d Complete bum eset Cancel i Gemer a Wither ation Chick Save Account Type Labeler Data Entry Username First Macnee Last Name Email Phone Draamaa Terie tcc Cag An fal on DUNE Orzanization Name Address 1 Address 2 City State Province DF Postal Country DIE l dakan Hay Fata VA 22033330 UA Labela DUNS E DINS City Siaa Prine JF Postal Cowntry Danza Name Akar E DTT363358 Fafax WA 22033330 USA BOS lee Jaden Hay 3 4 Labeler
20. he device is a Combination Product For entering Premarket information Click on Add Premarket Submission Number Check if the device is exempt from Premarket Submission Enter FDA Premarket Submission Number and the Supplement Number Action button allow users edit the information For entering FDA Product Code Click on Add Product Code Enter FDA Product Code Product Code Name is system populated from the FDA Premarket Submission database Distributed by www regulatorydoctor com for informational purposes only C Combination Produci gt GF Add Product Code GF Add GMDN Action x L GMDN 29 Action button allow users to edit the information For entering FDA Listing Number Click on Add Listing Number Enter a valid and relevant FDA Listing Number Action button allow users to edit the information For entering GMDN Code Click on Add GMDN Code Enter GMDN Code Name will be automatically updated by the system Action button allow users to edit the information Device Characteristics For Single Use Production Identifier s on Label Latex Information Lot or Batch Number G amp D Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 Manufacturing Date No No oF Serial Number No M Device labeled as Not made with natural rubber latex Expiration Date Donation Identification Number No Prescription Status MRI Safety ae What
21. ive medium designed to be used between the metal contact surface of an external defibrillator electrode of XNDZ External defibrillator electrode the paddle type and the patient s skin A defibrillator electrode pad is available in two basic designs 1 a thickened pad conductive gel or polymer layer reinforced by a non woven material or 2 a conductive adhesive pad with a metal contact on its outer surface This is a single use device A magnetized device used to test an inhibited or triggered type of pacemaker or defibrillator and cause an inhibited or triggered generator to revert to asynchronous operation The device is placed on the outside of the patient s thorax over the pacemaker defibrillator for analysis of the implanted device s function The magnet will activate the magnet sensitive relay in the pacemaker defibrillator and will change the function of the implanted device It is possible to evaluate the function of the implanted device via an electrocardiograph Cardiac pulse generator test TKHP magnet A portable electronic device intended for use at home to automatically detect cardiac arrhythmias ventricular fibrillation pulseless ventricular tachycardia in a sudden cardiac arrest SCA patient after which it audibly visually RROQZ Home automated external instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the Highlighted in the picture above is the FDA PT Code
22. mples in Appendix F 17 Distributed by www regulatorydoctor com for informational purposes only Access the Database To begin login as LDE user see Login section under Subsection 2 2 for detailed information The home page is displayed at login see figure below Click the Manage DI and Draft DI buttons or Manage DI from the menu bar Terrell Suggs Search v Manage DI LABELER Welcome Terrell Suggs Search function is temporarily disabled and will be enabled at a future date when t abase is populated y SEARCH DI Ress MANAGE DI 4 DRAFT DI 7 search public DI content manage DI records manage Draft DI records a FIND FDA PT CODE S find FDA preferred term code Manage Device Identifier DI Records Upon entry on the Manage Device page published and unpublished DI records available for view will be displayed in the table Click on a DI number to see DI record details You can filter for a specific DI record by typing in any of the fields provided DI Number Company Name Brand Name Version or model number or DI Record Status Published Unpublished Enter information into the field you desire to filter by and click Filter Results will appear in table at bottom of screen Click DI Number link to open DI record Open a published DI record from the Manage Device list You will see on the top left to Device Identifier Details page that the DI record is Published 18 Distributed by www regulatorydoctor
23. or regulating tobacco products Section 226 of the FDA Amendments Act FDAAA of 2007 and Section 614 of the FDA Safety and Innovation Act FDASIA of 2012 amended the Federal Food Drug and Cosmetic Act to add section 519 f which directs FDA to promulgate regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices The Unique Device Identifier UDI Proposed Rule was published on July 10 2012 followed by an amendment published on November 19 2012 modifying the implementation time frame for certain devices In developing the proposed rule FDA solicited input from a variety of stakeholders e g manufacturers global regulatory bodies the clinical community patient advocates to ensure that as many perspectives were incorporated as possible The UDI Final Rule was published on September 2013 Over the past year FDA has been working on the design and development of the Global Unique Device Identification Database GUDID This document 1s intended primarily to provide information about submitting data to the database for device Labelers entities that will be responsible for providing the data to the GUDID Please note that database enhancements will continue to improve user experience build in better validation rules and make other necessary changes as we learn from the initial roll out and implementation The FDA intends to periodically update
24. orrect the errors and click review again Once the record is validated the system notifies the user that the Review was successful When the user clicks Submit the DI record will be in Published or Unpublished state based on the DI Record Publish Date 20 Distributed by www regulatorydoctor com for informational purposes only Bip a hpg ard Davie bhener EH Fagg riai der Published DI Record Publish Date lt today available via Public Search ee eee eee l Frens Lie be T p Ss Gee e ey ete tne i Jepy Oe Baie oge Pte Dee enh rt eh a eee Ee WAI lairi Hrb M AH E Dara ee Dreri brg tel E beer baper be Deel Ble bee EL eed Bleed l Dj Di Cele eee Freer Ca DH D Arie kg ol i Sp 6 Le ee aaa 7 Dra Pabam on Darde Erjerei Peilin Prie bh Lir 7 ee es ee Bam L Ly Ee Leste ee Ue aa en er i mkm m ia a amal a as Tu mna Pa ma eo Lake Le Pier a ei Lee Co oto Bs Later Bete Gh J bmd a rp mmm rahia hH OPA bi iky Eemere By Beer Dr U m Bs b a Fe Jea A E eR E A I L AA If the DI record is Published the labeler will have 7 Calendar days called Grace Period to edit any fields on the DI record After the grace period expires non DI trigger fields are editable on the Published DI record The grace period will not start for an Unpublished DI record until the DI record is Published 21 Distributed
25. oubleshooting Internet Explorer Issues If you are using Internet Explorer IE 9 or 10 and see the following message Follow theinstructions below to troubleshoot Text Warning Your web browser is not supported for this GUDID release Please use a supported browser which is available under the About link Sorry for any inconvenience Turn off Compatibility View in Internet Explorer 9 and 10 1 Open GUDID in Internet Explorer 2 Seeifthe Compatibility View button appears in the Address bar If you don t see the button there s no need to turn off Compatibility View p https gudidfdagov gudid appn P i 3 Tap or click the Compatibility View button to turn off Compatibility View 4 The Compatibility View button should now appear grayed out https qudid fda gov gudid app n Change Mode and Document version Distributed by www regulatorydoctor com for informational purposes only 1 Open GUDID in Internet Explorer 2 Click F12 on the keyboard or click the Eskon in the right hand corner and click on Developer Tools 3 In the top toolbar set the Browser Mode to IE9 IE10 and the Document Mode to IE9 standards IE10 standards File Find Disable View Images Cache Tools Validate Browser Mode IE9 Document Mode IE9 standards EURU cs Comoe Sopi Proe Newok PT Ra Ss amp ee eS IDOCTYPE html PUBLIC WSC DTD XHTML 1 6 Transitional EN http www g TR xhtml H ihtml xmlns http www w3 org 1999 xhtml g
26. retrieve a forgotten username click Forgot Username Enter email address associated with the username and then click Send MyUsername You will receive an email with the username If you have more than one account linked to your email you will receive an email for each username in GUDID Note This function does not reset the password Distributed by www regulatorydoctor com for informational purposes only GUDID Login Search function is temporarily disabled and will be enabled at a future date when the database is populated Username WARNING WARNING WARNING WARNING WARNING Po This information system is provided for U S Government authorized use only Password System User Agreement a You are accessing a U S Government information system the Global Unique Device Identification ee Database The information system includes 1 this computer 2 this computer network 3 all Forgot Usemams Password computers connected to this network and 4 all devices and storage media attached to this network or to j a computer on this network Password must be 8 32 characters with at least one upper case letter one lower case letter one Any unauthorized or improper usage of this information system is prohibited and may result in disciplinary number and one of the following special characters action as well as civil and criminal penalties E a Y p 86 E Y ao By using this information system
27. s can be edited unlimited number of times However after each edit records need to meet all the business rules as defined in the system The system will automatically check for the publish date and move the records to published DI state on the day when publish date today Distributed by www regulatorydoctor com for informational purposes only 32
28. t 3 2 Common Functions Main Page URL https gudid fda gov gudid The Main Pageis displayed as shown below From this page you can login search among other functions as described in this document aces Damh o Mh a ba Distributed by www regulatorydoctor com for informational purposes only Login Screen From the GUDID log in screen enter your username and password for account management or data entry Please review the System User Agreement prior to logging into the GUDID At the first login you must change your password gt Note to system users When the Search functionality is enabled the search capabilities will N y be available as a front end Public Portal to the GUDID No login information will be required This public search will be restricted to non proprietary data About User Gui rs Global Unique Device A ye Identification Database GUDID Logo 7 R Menoio J Search v GUDID Login Login Panel WARNING WARNING WARNING WARNING WARNING Username This information system is provided for U S Government authorized use only System User Agreement Password You are accessing a U S Government information system the Global Unique Device Identification Database The information system includes 1 this computer 2 this computer network 3 all Forgot Username Password computers connected to this network and 4 all devices and storage medi
29. this document to reflect system changes and enhancements FDA s Guidance documents other Technical documents and FAQs including this technical document do not establish legally enforceable responsibilities t The UDI Final Rule http www fda gov udi defines labeler as any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any intended subsequent replacement or modification of the label and any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label except that the addition of the name of and contact information for a person who distributes the device without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler Distributed by www regulatorydoctor com for informational purposes only 2 How to obtain a GUDID Account In order to submit data to GUDID first an Organization account needs to be established In order to do so please refer to Global Unique Device Identification Database GUDID Draft Guidance for Industry PDF 3 6 MB Visit www fda gov udi to obtain an organization account 3 Getting Started 3 1 Browser Compatibility GUDID currently supports the following browsers Internet Explorer 9 and 10 Mozilla FireFox 17 22 Tr
30. urrent Password New Password Confirm Password Ch ari g F dssSwWwg gal You must change your temporary password to access GUDID functions Enter the temporary password a new password and confirm your new password View and Edit User Profile To view the User Profile click on the dropdown menu next to the username and role in the right hand corner On the User Profile screen you can make updates Distributed by www regulatorydoctor com for informational purposes only and save changes by clicking Save on the User Detail tab or Change your password on the Change Password tab Coordinator About UserGuide Logout Global Unique Device lt q ea ae SDE IEE N Home Search Manage Accounts OTE X User Profile for y required fields User Details Change Password First Name Last Name Email Phone Account Type Organization COORDINATOR y 4 Labeler Data Entry User D ID Global Unique Device About User Guide Logout Identification Database Home Search Manage Accounts AER v User Profile for lt lt required fields User Details Change Password First Mama Last Nama _ _ onl Account Type Organization LABELER 4 FDA PT Code Terrell Suggs Search Manage DI v LABELER Find FDA Preferred Term Code The Find FDA Preferred Term Code functionality is available to all logged in users and will allow a search on the Global Medical
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