Just a little over a week ago, the comment period on the FDA’s proposed UDI rule closed, and now it is up to the FDA to sort through the 300 plus comments received, with the goal of publishing a final rule by next May – or at least that’s when the FDA Safety and Innovation Act (FDASIA) says it needs to be published. But if that wasn’t enough to fill up the FDA’s holiday reading list, the agency today opened up another comment period, this time for 30 days and specific to a newly published list of devices that would need to comply with the regulation within TWO years after the final rule is issued.
This list provides clarity to an otherwise vague section in FDASIA that referenced “devices that are implantable, life-saving, and life sustaining.” Today, in the Federal Register, the FDA announced that it has published a list of devices it believes fall into this category. It’s a wide-ranging and somewhat lengthy list, ranging from sutures and surgical mesh to hyperbaric chambers, and as such warrants a close look by manufacturers that may be impacted and by providers who will hopefully use the UDIs for everything from supply chain processes to recall management. The majority of the devices are Class II, which otherwise would not be required to comply with the regulation until three years after the final rule. Others are Class I or unclassified and would otherwise not have needed to comply with the regulation until five years after the final rule. You can review the full list subject to this amendment at the bottom of the proposed rule. Just look for reference 12.
The FDA is interested in comments from manufacturers, as well as healthcare providers, on both the items included in the list and the accelerated timelines for compliance, including when the products need to have unique identifiers on the labels, when data on the products needs to be published to the FDA’s global UDI database and in some cases when direct part markings are required on the devices themselves.
You can comment on this amendment at the Federal Rulemaking Portal. Just search on Docket ID: FDA-2011-N-0090. But hurry. Comments are due by December 19.