Anyone who has tried to navigate the crowded aisles of a supermarket on a Sunday afternoon knows that some days and times are better than others to go grocery shopping. When it comes to making UDI data submissions to the FDA, the same rule holds true. Trying to do it at the same time as everybody else makes the process difficult and stressful, and takes a much longer time.
Class II medical device labelers in the midst of planning how they will comply with the FDA’s final rule on Unique Device Identification (UDI) may look at the upcoming September 24, 2016 deadline and think they can put decisions off. The experiences of Class III companies, however, demonstrated how important it is to start a UDI compliance program early.
The FDA has stated it expects to accept new GUDID account requests from Class II labelers beginning January 1, 2016. Although the compliance date is not until Sept. 24, 2016, several factors should incentivize labelers to start programs sooner rather than later.
1. More devices. Class II contains a very large volume of devices. Only about 10 percent of the medical devices on the market in the United States are Class IIIs, so the first group of devices required to comply with the final rule was relatively small. Not so for Class II. This class, which includes such things as powered wheelchairs and pregnancy tests, comprises about 43 percent of the medical devices on the market. As the volume of products grows, so too does the complexity of the data collection and the time the project will take to complete.
2. Same deadline. Once they have collected all the required data on each of their devices, Class II labelers will all be racing toward the same finish line. The sheer number of companies and devices involved is likely to complicate matters.
3. Same gateway. On the technical side, all GUDID submissions in HL7 SPL format will have to pass through the same portal, the FDA’s Electronic Submissions Gateway (ESG) – and they will not be alone. Like cars backed up at a tollbooth, GUDID submissions will join many other types of data submissions required by the FDA, including Adverse Event Reports , Abbreviated New Drug Applications, and Biologics License Applications.
4. Slower response time. As the volume of submissions increases, the existing FDA resources available to help resolve submission issues are likely to be stretched thin. Slower response times to resolve glitches or answer questions can delay a company’s compliance program.
5. Extensions unlikely. Although the deadlines for UDI labeling requirements for some devices – particularly certain types of single-use implants – were extended, most industry observers agree that deadlines are unlikely to be extended for Class II devices. Even in the case of the labeling deadline extension, manufacturers still were required to meet the original deadline for GUDID submissions.
Taken together, these factors present a compelling case; starting early to plan for UDI compliance will allow device companies to plan for the bottlenecks and delays that are likely to occur throughout the process. The labelers that fared the best in the first phases of UDI compliance were those that were led by top executives who were committed to completing their labeling and data submission projects early and therefore allowed plenty of time in the project schedule to reach that goal. Having time on their side allowed them to respond to any issues that might have arisen and still finish on time.
There is no penalty for early completion, and ten months remaining until the Class II deadline of Sept. 24, 2016 will pass quickly. Reed Tech has assisted dozens of device labelers in meeting the 2014 and 2015 compliance dates and has submitted over 100,000 device records to the GUDID. Contact us today with any questions.