Medical Devices

Request a GUDID Account

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.

Labelers of class I and unclassified devices:

If you are a labeler of only class I or unclassified devices (other than implantable, life-supporting or life-sustaining devices), and do not yet have a GUDID account, please note that FDA recently made public its intent to extend the UDI compliance date to September 24, 2020 for class I and unclassified devices that are not considered implantable, life-supporting, or life-sustaining. This includes GUDID data submission requirements. FDA will use this extension period to work with industry and other stakeholders to address existing challenges to the UDI system, and to optimize the quality and utility of data for higher-risk devices already in GUDID.

Because of this, at this time, we will provide GUDID accounts and technical support to labelers of class I and unclassified devices only as our limited resources permit; these labelers can expect significant delays in processing their GUDID New Account Requests. We apologize for this inconvenience and we thank you for your patience. New account requests for labelers of class III, implantable, life-supporting or life-sustaining, and class II devices will continue to be given high priority for processing.

In addition, as part of our effort to optimize the quality and utility of the UDI data, during 2017-18, we will be implementing improvements to GUDID to make it more efficient for labelers to make initial submissions and update existing device identifier (DI) Records. We will also resolve and clarify issues that may have caused confusion for labelers and users of GUDID data. Existing DI records may need to be changed after we implement our improvements.

Thus, rather than submitting data or obtaining a GUDID account at this time, we encourage class I and unclassified device labelers to instead take full advantage of the time provided by our intent to extend the applicable UDI compliance dates to better prepare for what is required for UDI, including establishing fully developed labeling plans and procedures, and optimizing the coordination of their internal data and organizational processes. We plan to direct more of our resources towards assisting class I and unclassified device labelers (including more efficient processing of GUDID accounts) in early 2019, and will notify industry at that time. 

To request a GUDID account:
  • 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.

All fields are required.

 

Page Last Updated: 08/22/2017
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