Скачать или смотреть FDA Unique Device Identifier (UDI) Requirements

The U.S. Food and Drug Administration (FDA) published a final rule requiring all medical devices distributed in the U.S. to bear a Unique Device Identifier (UDI). Device labelers must also submit device data to FDA's Global Unique Device Identification Database (GUDID).

Video Transcript:

In 2013, the U.S. Food and Drug Administration was mandated to implement regulations requiring that medical devices distributed in the United States bear a Unique Device Identifier, known as a UDI.
A UDI consists of two parts: a device identifier and a production identifier.

The DI portion of a UDI is used to identify the device type. Device identifiers are provided by an FDA-accredited issuing agency.
The PI portion of a UDI identifies a device's production information, such as its batch number or expiration date.

If a company manufactures multiple batches of the same device, the DI for each batch will be the same, but the PI will be different.
UDIs must be included on device labeling and must be displayed in human readable and machine readable format. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must also be placed on the device itself.

Device labelers are responsible for complying with FDA’s new UDI requirements. FDA defines a device labeler as "the person who applies or modifies the label of a device with the intent that the device will be commercially distributed in the U.S. without any other alterations to the labeling."

Labelers must also submit information about each device labeled with a UDI to a publically searchable database called the Global Unique Device Identification Database.

A separate DI is needed for each variable of a device, such as size, color, or style, so the number of UDIs for a single type of device can add up quickly.

UDI compliance dates depend on the classification of a device.

Labelers can have experienced regulatory specialists, such as Registrar Corp, submit their required UDI information to FDA. Registrar Corp provides medical device companies with cost effective solutions for quick and easy FDA compliance.

If you need assistance determining how FDA’s UDI requirements apply to your devices or answers to other questions about FDA regulations, please feel free to contact Registrar Corp. Simply phone our US office at +1-757-224-0177 or visit our website at www.registrarcorp.com.