RAPS

FDA Releases Unique Device Identification Rule, Reflecting Dozens of Changes Sought by Industry

In a highly anticipated move, the US Food and Drug Administration (FDA) has announced the final release of the Unique Device Identification (UDI) rule, reflecting a number of changes called for by ...
RAPS

US FDA Amends eMDR Rules to align with Unique Device Identification Program

Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) ...
Becker's ASC

FDA Proposes Medical Device Unique Device Identification System

FDA has announced it has proposed that most medical devices distributed in the United States carry a unique device identifier, according to a news release. The announcement comes in response to ...
Fierce Healthcare

American Hospital Association urges accelerated passage of unique device ID rule

The American Hospital Association and a large healthcare purchasing group are urging the Food and Drug Administration to accelerate adoption of a proposed unique device identifier (UDI) rule for ...
Becker's ASC

APIC Urges FDA to Issue Proposed Rule on Unique Device Identification for Medical Devices

The Association for Professionals in Infection Control and Epidemiology, joining with other members of the Advancing Patient Safety Coalition, has sent a letter to the FDA urging for the immediate ...