The UDI compliance deadline of October 24, 2015, for labelers of Implantable, Life Supporting and Life Sustaining (I/LS/LS) devices recently passed. While the FDA and industry expected the increase in the number of I/LS/LS records submitted in 2015 from those Class III records submitted in 2014 to cause significant challenges for the medical device industry, the strain placed on the FDA’s Global Unique Device Identifier Database also resulted in some unexpected issues. In October, Reed Tech saw a 38% increase in submissions by its client companies to the FDA’s GUDID over September’s volumes as companies neared the FDA’s compliance date. With that trend mirrored across the industry, these increased submission volumes caused problems as so many companies worked to submit their records simultaneously.
One issue caused by the increase in the number of submissions was the high number of records for which an ACK 3, the final acknowledgment sent after a record has been processed, was not received from FDA. During high volume periods especially, records can sometimes become caught in the GUDID system after submission. When no ACK 3 message is received, a “hung record” must be resubmitted to FDA. This means that labelers must track the status of each record submitted to determine whether the final acknowledgment has been received from the FDA. The number of hung records observed by Reed Tech rose sharply in September and October as the volumes of records submitted to the GUDID spiked in the final weeks before the compliance date.
The increase in the number of hung records caused significant delays for device companies trying to meet the 2015 compliance date. For many labelers who worked hard in the previous months to collect their data, the actual submission process did not go as smoothly as they hoped. In addition to needing to make corrections to those records found to contain errors, some labelers needed to work around the clock during the final days before the deadline monitoring the status of last-minute submissions and resubmitting those records that did not receive final acknowledgment messages.
There is an important lesson here for Class II labelers as they put their compliance programs in place for 2016. The number of records to be submitted to the GUDID in 2016 far exceeds those submitted in 2014 and 2015. It is crucial to understand that this dramatic increase in submission volumes across the industry is likely to cause delays and problems in the final weeks before September 24, 2016. We strongly encourage Class II labelers to begin their submissions to the GUDID well in advance of that date and to build in extra time for sorting out errors and resolving any issues that may result from so many companies trying to submit to the GUDID at the same time.
To help Class II labelers meet these challenges, Reed Tech has built its GUDID submission solution to monitor the status of each submitted record and automatically resubmit those records which do not receive an ACK 3 message from FDA. This is just one of the features we have developed to help our clients based on our experience submitting over 115,000 unique records to the GUDID. The experts at Reed Tech can help you get your UDI compliance program off to the right start. Contact us today with any UDI questions you may have. We will be happy to help.