Newsflash: The FDA has published an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). There is a 30 day comment period for this amendment (and this comment period is only for the requirements in this amendment – not the rest of the proposed rule). The draft list of devices subject to this amendment can be found at the bottom of the original proposed rule in the list of references as reference 12 – the FDA also welcomes comments on the accuracy of this list. AHRMM will review the amendment and comment as necessary in the 30 day comment period.
Impact/Benefits of Proposed UDI Rule for Providers:
Impact: The UDI rule in and of itself will not put any regulatory requirements on providers. However, providers are instrumental to a UDI system's success; if providers don't use the unique identifiers, much of the intended value of UDI will be lost.
Benefits: A unique medical device identifier would provide an important means for hospitals to better track medical devices for use in patient care, act in event of safety recalls, and manage their supply chains. UDIs also can be incorporated into electronic health records. Read a full list of benefits here.
UDI Webinar with FDA
7/31/12 webinar with FDA Senior Advisor Jay Crowley, author of the proposed regulation.
Download a PDF of this presentation
UDI Readiness Video Series |
Part 1
Karen Conway is Industry Relations Director at GHX and an AHRMM board member. She also serves on AHRMM's ad hoc committee preparing comments to the FDA on the proposed UDI rule.
UDI Resources:
- Proposed Rule on UDI
- GS1 Executive Summary of the Proposed UDI Rule
- Sign up for email updates on UDI from the FDA
- Blog posts on UDI from The Healthcare Hub.