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How to Register a Medical Device with the FDA GUDID

The FDA GUDID  AccessGUDID  site is actually most helpful with this

This link shows you what you need to do to prepare to load an MD

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm427424.htm

 

This is a shortened version of the information on the GUDID website

 Who:

Labelers required to submit information to the GUDID must first request a GUDID account. A GUDID account identifies the labeler in GUDID and is required regardless of the submission option chosen by the labeler – Web Interface or HL7 SPL submission option. Note that the GUDID account is not specific to a submission type, (i.e., a labeler does not need to have a separate GUDID account for each submission option).

FDA is accepting GUDID account requests from labelers of all classes of currently marketed devices. Before requesting a GUDID account, labelers are encouraged to take steps to prepare to submit information to the GUDID.

Prepare

FDA’s experience and feedback from industry indicate that device labelers often take a number of actions related to organizing, collecting and validating data --- before they get a GUDID account or submit device identifier (DI) records. Importantly, labelers may house necessary information in multiple systems and locations, making internal system coordination a key aspect of preparing data for the GUDID. We strongly encourage labelers to take the following steps to ensure their readiness to meet UDI requirements and streamline the GUDID submission process:

 

  • Review UDI guidance documents and resourcesto create an internal action plan/timetable for preparing data for the GUDID.
  • Work with FDA-accredited issuing agenciesto assign and maintain UDIs. Establish processes for physical labeling.  ****  GS1 NZ can issue you a GTIN (Global Trade Item Number) which is an approved UDI (Unique Device Identifier).  If you do not already have one, please contact the GS1 NZ Help Desk - 0800-10-26-53
  • Establish standard operating procedures for records management.   **** Using the GS1 NPC for maintaining your product data meets this requirement.  If you do not use the GS1 NPC, then you should have some other internal mechanism for maintaining the GUDID record(s)
  • Gather data required for GUDID DI records based on the GUDID Data Elements Reference Table (March 11, 2019).     *****Please click this link for the Data Elements
  • Understand the GUDID account structure and user roles as shown in the GUDID Guidance (see figure 1).
    • Identify individuals for the GUDID user roles and ensure that they understand GUDID functionality and responsibility for their user roles
  • Determine a GUDID submission option (GUDID Web InterfaceHL7 SPL submission).   *****Please select which you wish to use and then follow the link
    • If choosing HL7 SPL submission, establish a FDA ESG accountand complete required testing.
  • Subscribe to the UDI mailing listto be notified about updates for the UDI program.
  • Subscribe to the GUDID mailing listto be alerted to database changes and GUDID system status updates.

 

Once you have Prepared  - then you need to request an Account

 

To request a GUDID account:

  • Change your filter settings to allow emails from GUDIDsupport@fda.hhs.govand noreply@salesforce.com so that you will receive future communications from the help desk.
  • Submit a GUDID New Account Inquiry.
  • The FDA UDI Help Desk will email you the GUDID New Account Request document in a fillable PDF format.
  • If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was sent to your spam/junk folder, please adjust your spam/junk filter to recognize the FDA UDI Help Desk as a contact to ensure you receive future emails.
  • Enter the correct information into the document.
  • After completing the GUDID Account Request document, reply to the FDA UDI Help Desk email and attach the completed document.
  • Upon receipt of the completed document, an FDA Help Desk Analyst will review your request and respond as soon as possible.
  • For all technical questions relating to accessing or setting up your GUDID account, please contact the FDA UDI Help Desk.

Please fill in the information below to initiate a GUDID New Account Inquiry.

 

 

Please click this link to create your request for a GUDID Account  - scroll to bottom of page for the form

 

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416113.htm

 

NEXT STEPS

 

To Launch the FDA GUDID Web Interface

Click on this Link

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416117.htm

Scroll down until you see this – and click

 

The GUDID User Manual can be found on the Help Center

Under National Product Catalogue / FDA GUDID

 

To assist labelers in submitting data to the GUDID, the FDA has created a GUDID User Manual and the GUDID Unlock User Manual. This document contains step-by-step technical instructions for submitting data via the GUDID web interface, including screenshots. The FDA intends to periodically update this document to reflect system changes and enhancements.

 

Resources for You

Subscribe

Sign up to get email notifications on GUDID database updates and system status.

Enter your email address by clicking on this link to take you to where you subscribe

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm416125.htm

 

Post Market Requirements for FDA GUDID

There are specific requirements that the FDA require once you have registered your medical device – this link will take you to that section of AccessGUDID web site

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm

 

GS1 recommends that you read the Post Market Requirements so that you are aware of what is required of you.

 

If you get stuck  - would recommend you contact the FDA GUDID directly

 

Created:  2 April 2019

 

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