With some notable exceptions, most public comments received by FDA on its proposal to require unique device identifiers (UDI) support both the essential thrust and the details of the proposal.

Channeling Johnny Nash and the 1972 classic song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration issued its final guidance titled, “Unique Device Identification System: ...

FDA has finalized guidance on the form and content of unique device identifiers used to track medtech products through the supply chain. The final text responds to, but in some cases holds firm ...

The Food and Drug Administration has released its final rule requiring most medical devices distributed in the United States to include a unique device identifier, according to a report from Premier ...

In today’s world – whether at work or at home – I’d be lost without the smartphone that helps me do so much more than just communicate. It knows where I am now and how to get where I want to be next.

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...

The FDA’s device center has posted a draft guidance that addresses unique device identifier (UDI) code requirements applied to low-risk products. The select update offers enforcement discretion in ...

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...

Australia’s Therapeutic Goods Administration reported June 30 several new regulatory requirements are in effect, including a new mandate regarding the use of unique device identifiers for implanted ...