December 19, 2014
In case you missed it, the FDA issued this update on UDI yesterday:
Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act). The FDA’s Center for Devices and Radiological Health (CDRH) would like to take this opportunity to summarize recent and upcoming UDI activities and deadlines. The next two compliance dates for UDI requirements are:
September 24, 2015, for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices
September 24, 2016, for class II devices
Global Unique Device Identification Database (GUDID) Data Submission:
In January 2015, we will begin accepting GUDID account requests from labelers of I/LS/LS devices. Later in 2015, we plan to accept GUDID account requests from labelers of class II devices. We strongly encourage all device labelers to take steps to ensure their readiness to meet UDI requirements well in advance of actual data submission to GUDID. This will provide labelers with ample opportunity to assess their ability to meet requirements. Including data submission to the GUDID, by their deadline, and to work with us if they have any difficulties in compliance. Suggested steps are included on the UDI website.
Additionally, in January, we will host a webinar to assist Class II and I/LS/LS device labelers in preparing to comply with the UDI rule. Notification of webinar specifics will be sent directly to these device labelers in early January. The webinar will include overviews of UDI requirements and guidance on getting started with the GUDID.
UDI Policy:
We continue to collaborate with the industry on UDI implementation issues that arose in 2014, including GUDID data submission for contact lenses/IOLs, and the development of approaches to ensure the UDI is readily available at the point of use for non-sterile implants. We recognize that several other policy issues are of significant interest to the industry; we hope to address a number of them in 2015, such as UDI direct marking requirements, convenience kits, posting decisions on UDI exceptions and alternatives, and issuing additional Frequently Asked Questions (FAQs).
The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. Device labelers that want to retain the use of FDA-issued NHRIC or NDC labeler codes under a system for issuing UDIs were required to request such continued use by September 24, 2014. If you intend to retain the use of a previously issued FDA labeler code within your UDI system but have not made such a request, we urge you to do so as soon as possible.
UDI Adoption and Use:
We continue to collaborate with stakeholders, including the Pew Charitable Trusts, the Office of the National Coordinator for Health IT (ONC), and the Brookings Institution, to promote and facilitate UDI adoption in healthcare settings.
We are collaborating with the National Library of Medicine (NLM) to provide the public with search and download access to published records in the GUDID in the spring of 2015. The GUDID search will enable users to retrieve published GUDID data based on parameters of interest. The GUDID download function allows users to download all published GUDID data simultaneously.
Finally, we’d like to reaffirm our plans to implement this critical system over several years—and underscore the fact that we fully intend to be flexible during this time. Our primary focus is on implementing the system correctly and actively assisting companies in meeting the system’s requirements. As with the implementation of many new systems, it can take time to understand and comply with new requirements. Widespread, strict enforcement of associated deadlines and requirements is not necessarily the best way to achieve compliance at this time.
To date, the industry has been very willing to work with CDRH, and we have experienced excellent efforts and strong feedback. We urge labelers experiencing difficulty fulfilling UDI requirements to contact us through the FDA UDI Help Desk.
We will continue to work diligently to provide the medical device industry, healthcare systems, clinicians, and patients with the assistance and information needed to implement and use UDI successfully. For additional information, please visit www.fda.gov/udi or contact the FDA UDI Help Desk.
