Beginning in September of 2014, medical device manufacturers have faced a series of data submission and maintenance requirements from the FDA as part of its Unique Device Identification (UDI) initiative. The agency phased the compliance deadlines by device class, requiring the highest risk device records to be submitted first to its Global Unique Device Identifier Database (GUDID). Though most of the industry’s recent attention is focused on the extended Class I device deadline in 2020, there are still some important deadlines this year on September 24, 2018.
The timeline below shows the FDA’s current due dates for GUDID submissions.
Class II Convenience Kits Due in 2018
Class II convenience kit submissions were originally due in 2016, along with the rest of Class II devices, but FDA extended the deadline for two years. That means labelers of Class II convenience kits face a 2018 FDA UDI submission compliance date.
A convenience kit, according to the draft guidance document on the subject, is defined as “two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.” We recommend opening the guidance document above and reading through the examples provided by the FDA.
A convenience kit falls under the 2018 extended deadline if the highest risk class contained within the kit of multiple devices is Class II. In other words, a kit may contain mostly Class I devices, but must have a UDI assigned and submitted to GUDID by September 24, 2018 if one or more Class II devices is also present.
In its letter to industry, FDA also extended the compliance date to September 24, 2018 for repackaged Class II single-use devices not individually labeled with UDI and confirmed the same compliance date for Class II device constituents in certain Combination Products. Also note, September 24, 2018 is the compliance date for Class II Direct Marking and the expiration of the three-year extension for I/LS/LS devices in inventory.
Another 2018 Deadline—NHS eProcurement
In addition to the FDA Class II Convenience Kit deadline, device companies should be aware of the 2018 deadlines of the National Health Service (NHS) eProcurement program. NHS England, the largest purchaser of medical devices in the United Kingdom, is requiring device product data to be provided electronically through the Global Data Synchronization Network (GDSN). While this is not a regulatory requirement, it is essential for any device company marketing its products in the U.K. to understand. Like the FDA, the NHS has introduced a phased implementation based on device class to provide product and pricing data through its eProcurement program. (Please note, pricing data is provided separately from product data and through a different system.)
You will see from the timeline above that September 30 of this year brings the submission deadline for Class IIa and IIb product data. If your company markets Class IIa or IIb products in the U.K., you should be actively working on your eProcurement implementation.
Though 2018 deadlines may affect fewer products than previous years, many device companies still face important UDI and eProcurement deadlines in September. With less than three months to go before both deadlines, affected organizations should be actively executing, if not already finished, with their submissions and moving into maintenance modes for these device records. If you think your company may be affected and you are worried about missing the deadline, contact the team at Reed Tech. We will be happy to help.