FDA’s Proposed UDI Rule Will Require ‘Master Data’ Collection, Maintenance
This article was originally published in The Silver Sheet
Executive Summary
FDA’s forthcoming proposed rule on its Unique Device Identification (UDI) program will require manufacturers to gather specific information about products and package it together as “master data.”
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News In Brief
Senators want to know why it’s taking so long for the Office of Management and Budget to release FDA’s proposed UDI rule; CDRH’s 2013 budget increase would come from industry.
Industry Happier With FDA's Shorter List Of UDI Data Requirements
As FDA puts the finishing touches on its planned unique device identification system, it is reporting that "many fewer issues and questions now remain" regarding the expected requirements for manufacturers and distributors.
Industry Happier With FDA's Shorter List Of UDI Data Requirements
As FDA puts the finishing touches on its planned unique device identification system, it is reporting that "many fewer issues and questions now remain" regarding the expected requirements for manufacturers and distributors.