The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I Medical Devices be included in the GUDID without exception.
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AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP). The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
On November 21, 2013, AHRMM submitted electronically
AHRMM supports the concept and use of Comparative Effectiveness Research (CER) to provide evidence-based data to help inform purchasing decisions. CER is designed to support healthcare decisions by providing objective conclusions after comparing the effectiveness, benefits, and potential harm of various medical equipment, devices, or treatment options for specific episodes of care or states of disease. By using objective data provided by CER, healthcare supply chain professionals have the ability to:
This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.
An announcement of the Final Rule issued by the IRS.
AHA Special Bulletin on the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) guidance adding roadblocks for hospitals working to become meaningful users of electronic health records (EHRs) and receive incentive payments promised in the stimulus bill.
The Official Comment of AHRMM to the United States Department of Health and Human Services Food and Drug Administration (FDA) regarding Unique Device Identification for Medical Devices Docket No. FDA-2011-N-0090
AHRMM comments to the FDA regarding 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).