RAPS

FDA loosens UDI requirements for lowest risk devices, extends deadline for others

The US Food and Drug Administration is relaxing its unique device identified (UDI) rule requirements for low-risk class I consumer health products. Other class I and unclassified devices will still ...
RAPS

FDA Delays UDI Requirements for Low-Risk Devices

The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and ...
Becker's Hospital Review

FDA issues final guidance on UDI direct marking requirements: 4 things to know

The FDA published a final guidance Nov. 17 on unique device identifier marking requirements. Here are four things to know. 1. The agency first released a draft guidance on UDI direct marking — which ...
Hosted on MSN

FDA’s UDI guidance ‘ambiguity’ could lead to inconsistent implementation

The perceived ambiguity of the US Food and Drug Administration’s (FDA) guidance on Unique Device Identifier (UDI) requirements for combination medical devices could lead to inconsistent implementation ...