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AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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.
AHRMM Awareness Brief: Draft Guidance for UDI Convenience Kits
Issue Brief
This Awareness Brief provides a quick reference to the Draft G
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
Letter/Comment
On November 21, 2013, AHRMM submitted electronically
Announcement of GUDID Release 2.2 Deployment and Document Updates
Advisory
An announcement of GUDID Release 2.2 deployment and document updates.
AHRMM LUC Comments to the FDA’s Communications About the Safety of Medical 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.
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Actio
FDA Releases Proposed Rule on Unique Device System for Medical Devices
Advisory
The FDA UDI ruling has finally arrived - the proposed rule has published.
Quality Advisory: Ethylene Oxide Sterilization of Medical Devices
In light of closures and potential closures of certain facilities that use gas ethylene oxide (EtO) to sterilize medical devices prior to their distribution and use, the Food and Drug Administration (FDA) is concerned about the future availability of medical devices and possible medical device shortages. In addition to background on the issue, this advisory highlights potential alternatives to EtO, including the advantages and disadvantages of each, as well as a resource to identify companies that sterilize instruments and equipment in the U.S.
AHA Comments to FDA Re: Blood Glucose Monitoring Test Systems
AHA's comment on the Food and Drug Administration’s draft guidance on blood glucose monitoring test systems for prescription point-of-care use.