A recent US Food and Drug Administration (FDA) notice proposed reverting to a 7-day grace period to review, edit and correct records that medical device manufacturers are required to submit to the agency’s global and publicly available unique device identification (UDI) database.
The proposal, posted late last December, responds to feedback from users of the Global Unique Device Identification Database (GUDID) after FDA’s Center for Devices and Radiological Health (CDRH) changed the original 7-day grace period to 30 days via GUDID final guidance from
2014. The temporarily changed grace period came in anticipation of a spike in submission volume and more new users learning how to use GUDID.
Medical device manufacturers and other stakeholders were encouraged to submit comments on the new proposal by 18 January to end the temporary extension of the GUDID grace period beginning in early 2019.
"We have received user feedback, particularly from healthcare providers, that 30 days is too long to wait for key information on devices used in patient care to be made available for public use," FDA said. "In rare circumstances, records need to be corrected after submission. The GUDID grace period is intended to provide labelers a second chance to review and make edits and/or corrections to a GUDID device identifier record after it is published but before it is released to the public on AccessGUDID and openFDA,
" the agency added.
The proposal speaks to issues still facing both agency staff and industry with the complex implementation of a nationwide UDI system. The agency's plans for a phased-in UDI system implementation surfaced in 2013.
Lena Cordie, president and founder of consulting firm Qualitas Professional Services, noted in an interview with Focus
that the proposal to revert to the original grace period was to be expected. Yet it was “long overdue” and the original grace period should not have been changed as the issues have lingered for years, Cordie argued.
It remains to be seen how the reversal would impact upcoming deadlines on devices that have yet to enter the UDI system. Class III and II devices have been mandated to comply with requirements on UDI labeling and GUDID submissions since 2014 and 2016, respectively. UDI data on class I and unclassified medical devices were set requirements as of last September, but these requirements will not be enforced by FDA until next year.
Challenges that emerged with the UDI transition led one- or two-year extensions on compliance. Deadlines pushed back in 2018 include an extension
for GUDID submissions and direct marking requirements on class I and unclassified devices in January and an extension
on submissions for combination products’ device components in June. FDA’s immediately in effect guidance from January was superseded
in November 2018.
The timeline to complete the UDI transition has now been delayed to 2022 as a result of the extensions on the varying requirements. A shorter grace period on submitted UDI records prior to these being made public could allow industry to leverage a string of GUDID “system enhancements” implemented 2018. This could in turn put both agency staff and industry in a better position to deliver on the promises of UDI adoption at the patient level.
The promised benefits include improved patient safety, cost savings from earlier interventions and reduced disruptions to supply chains. These coincide with FDA’s recently renewed push to extend least burdensome principles across total product life cycles. The assertion the agency made with its GUDID proposal that manufacturers need to have control of their own UDI data was “spot on” for these reasons, argued Cordie.
The GUDID system changes included a newly added
feature to allow labelers unlock and edit their device identification (DI) records, fix any data submission errors and reduce delays in publishing submitted DI records.
“In practice, the grace period has not been utilized as intended,” CDRH wrote
last March. “We have gotten frequent requests to assist labelers to correct data after the grace period, when the record has already been released to the public. To ensure quality [DI] information is available to the public, the ability to ‘unlock’ a device record(s) for error correction after the grace period is being implemented as part of” the GUDID changes.
GUDID system changes were largely centered on greater data quality in DI records, said Cordie. Prior to these changes, Cordie noted that “there was an ability to put in bad data entries” over poor understanding of the new requirements. Yet she also argued that labelers of class I devices are likely to face even more issues soon because they do not necessarily have the data entry knowledge of those who have used GUDID for years.
Yet another UDI compliance challenge that is currently still facing industry relates to CDRH’s short-staffed UDI team as this oftentimes leads to delayed responses to pressing questions, Cordie argued. As an example, Cordie said the agency's UDI team took about one month to respond to one of her questions just last fall.
As the bumpy road to UDI adoption continues, the yet to be finalized 2016 guidance on convenience kits, a lack of GUDID standing in electronic health records and the role of UDI on a global scale are additional pressures.
Cordie also called for clarity around how UDI systems will be implemented across International Medical Device Regulators Forum (IMDRF) members, such as China and the EU, to support industry. IMDRF is currently working on an UDI adoption guidance. Its pending guidance seeks to address risk of confusion. It would prove to be particularly useful in IMDRF’s new pursuit for a medical device single review program, according to Cordie.
GUDID Grace Period Change Notice