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New Developments in UDI and GUDID Regulations

Registrar Corp is committed to keeping industry up to date on FDA’s Unique Device Identifier  (UDI) requirements and recently attended the 2018 UDI Conference in Baltimore. The following blog summarizes new and updated information related to UDI and Global Unique Device Identification Database (GUDID) regulations.

Background

In September 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, which requires most medical devices to carry a UDI. A UDI is a numeric or alphanumeric code consisting of a device identifier (DI) and a production identifier (PI) that must be placed on the device label and on the device packaging. The labeler is responsible for complying with this rule.

Compliance Deadlines

The compliance deadlines for Class II devices and for Class III devices have already passed. In June 2017, FDA informed industry that it intended to extend the compliance deadline for these devices due to complex policy and technical issues, among other things.  In January 2018, the Agency issued a guidance document detailing how it would utilize its enforcement discretion:

For Class I and unclassified devices manufactured and labeled on or after September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2020
  • Direct Marking requirements beginning September 24, 2022.

For finished class I and unclassified devices manufactured and labeled before September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2021.
  • Direct Marking requirements beginning September 24, 2022.

 

Recent Enhancements and Fixes to GUDID Submission Process

 

GUDID Coordinators Now Able to Correct Errors After the DI Record Grace Period

The labeler of a device with a UDI is responsible for submitting information about the device to the Global Unique Device Identification Database (GUDID), a public database that contains important identification information about every device with a UDI. In order to ensure data quality, FDA has taken steps to make correcting errors by editing device records easier.

Previously, unlimited edits were only possible during the 30 day grace period following initial publication. After the grace period, edits could only be made through a difficult process. Now, the GUDID Coordinator user has the ability to “unlock” device records. Once previously submitted device records have been unlocked, errors may be corrected. It should be noted that the records’ history will be saved and the public will be able to see what edits have been made.

 FDA to make Premarket Numbers Public

FDA has announced plans to grant the public access to the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI). This data is tentatively scheduled to be made public on July 2, 2018. FDA recognizes that this information may be sensitive and will give labelers the option of keeping their premarket numbers confidential. Specifically, FDA will use the confidentiality information that is included in the device listing information submitted to the FDA Unified Registration and Listing System/ Device Registration and Listing Module (FURLS/DRLM). If a proprietary name is marked confidential in DRLM as part of the device listing information, then FDA does not plan to make the corresponding premarket numbers in GUDID DI record(s) public.

Labelers who would prefer to keep the their premarket numbers confidential may find it advisable to carefully scrutinize and potentially alter the confidentiality designations assigned to the DRLM proprietary names in their device listing records in order to ensure that these designations correspond to their preferences.

Meeting FDA GUDID and UDI Requirements

The deadlines for complying with FDA GUDID and UDI requirements are approaching or have already passed. Therefore, it is prudent for medical device labelers to take measures to ensure that they are in compliance with these complex regulations. Medical device labelers may wish to seek the assistance of Registrar Corp’s Regulatory Specialists, who possess expert knowledge of relevant FDA regulations and can provide guidance on which UDI deadlines and requirements apply to particular devices.

Registrar Corp can provide assistance  by acting as a facility’s Regulatory Contact for UDI purposes, submitting the required device information to GUDID on behalf of the labeler, or by altering the confidentiality information submitted to DRLM in order to ensure that premarket numbers remain confidential.

For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Adviser 24 hours a day: www.registrarcorp.com/livehelp.