Tips and Tricks

What is a Udi (Udi)?

What is a Udi (Udi)?

A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following: Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

What are the compliance dates for UDI marking?

Compliance Dates. Requirements. September 24, 2018. A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

Where do I submit data for UDI labels?

Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. The FDA recommends that device labelers:

Will the FDA enforce UDI labels before 2022?

The guidance explains that, at this time, the FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), Direct Mark (21 CFR 801.45), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before September 24, 2022.