Medical Devices

Request a GUDID Account

Labelers required to submit information to the GUDID must first request a GUDID account.

Beginning February 1, 2016, the FDA will accept GUDID account requests from labelers of class II devices. These labelers are encouraged to obtain a GUDID account as soon as possible to allow adequate time for system compatibility testing and data submission.

The FDA will also continue to accept GUDID account requests from labelers of class III devices; devices licensed under the Public Health Service Act (PHS Act); and implantable, life-supporting and life-sustaining (I/LS/LS) devices.

The 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 by submission type, i.e., a labeler does not need to have a separate GUDID account for each submission option.

Before requesting a GUDID account, labelers are encouraged to take steps to prepare to submit information to the GUDID

To request a GUDID account:

  • Submit a GUDID New Account Inquiry.
  • The FDA UDI Help Desk will email you the GUDID 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.

All fields are required.

 

Page Last Updated: 02/10/2016
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