Two papers in JAMA Internal Medicine highlighted separate, but important issues concerning the US Food and Drug Administration’s authority to modify package inserts and the effect of a recently ...
Want a sustainable, extendable UDI program? Here are five reasons why your medical device company needs to implement an Enterprise Labeling Solution. Compliance with the UDI rule requires a ...
On September 24, 2013, FDA published its final rule for a system of Unique Device Identification (UDI). The rule has been a few years coming, so industry insiders that had time to get intimate with ...
Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials ...
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved ...
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs ...
Xerafy's RFID helps control and track medical devices and surgical instruments in hospitals globally
A recent regulation push for UDI in the U.S., EU, Australia/New Zealand, and China paves to way for the deployment of Surgical Tracking (SIT) systems in hospitals. The U.S. FDA is several years into ...
New solutions deliver enterprise-grade data access and streamlined EUDAMED compliance, driving smarter, faster decisions across the business Rimsys, the global leader in Regulatory Information ...
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