FDA Proposes to End Temporary Extension of GUDID’s Grace Period to Improve UDI Data Quality
January 17, 2019

December 18th, 2018, the U.S. Food and Drug Administration (FDA) issued the public notice: Unique Device Identification System: Grace Period Change and Proposed Modifications to the Global Unique Device Identification Database (GUDID), and opened a docket for comments on its proposal to end the temporary extension of the GUDID grace period, which is due January 18th, 2019.

According to Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff issued on June 27th, 2014; FDA had initially implemented a seven-calendar day grace period starting the day after the GUDID DI record was ‘Published’. This grace period was intended to provide labelers a second chance to review and make any edits and/or corrections needed after publication and before public release on AccessGUDID and openFDA. However, September 16th, 2014, FDA announced via GovDelivery that the grace period was temporarily extended to 30 calendar days, to accommodate new users who were beginning to learn GUDID and to manage processing the large volume of incoming GUDID submissions.

In order to avoid users waiting for the 30-day grace period to end before the records are published and available, FDA currently intends to return to the seven-calendar day grace period in early 2019. Additionally, labelers now have the ability to ‘unlock’ their records for editing after the grace period has passed, thus reducing the need for a 30-calendar day grace period. Moreover, this limited editing capability after public release ensures that records are not constantly changing for GUDID data users.

Fully realizing the benefits of the unique device identification system depend on UDI being integrated into data sources throughout the healthcare system, including in the supply chain, electronic health records, and registries. And that this requires UDI data to be of a high quality such that all stakeholders in the healthcare community have enough confidence in the accuracy and completeness of that data. November 5th, 2018, FDA issued an immediately in effect guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as follows:

For Class I and unclassified devices manufactured and labeled on or after September 24th, 2018;

For finished class I and unclassified devices manufactured and labeled before September 24th, 2018;

Labelers and GUDID users are always encouraged to use the FDA UDI Help Desk form to submit any questions related to UDI and the GUDID. Magellan platform is continuously updated with the most recent publications on Medical Devices and IVDs, please contact our team for more details on how Magellan could assist you in being abreast of and implementing all global regulatory updates.