Search Results

The default setting for search results displays All Content. If you prefer to see recent content only, please adjust the date filter.

Filter your results:

Types

Topics

7 Results Found

AHRMM LUC Comments to the FDA’s Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices

The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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AHRMM Awareness Brief: Draft Guidance for UDI Convenience Kits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AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)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.