U.S. FDA Unique Device Identifier (UDI) Compliance Date Quickly Approaching

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For the first time this September, FDA will require certain medical devices to bear a UDI. Registrar Corp informs the industry of the new UDI regulation.

Registrar Corp Assists Companies with U.S. FDA Regulations
September 24, 2014 will mark the first of many compliance dates.

Yesterday, the U.S. Food and Drug Administration (FDA) released the “Unique Device Identifier System: Frequently Asked Questions, Vol. 1,” a guidance for those with questions about FDA’s final rule on the Unique Device Identification System that was published last year.

September 24, 2014 will mark the first of many compliance dates for the new rule, which requires all domestic and foreign medical devices distributed in the U.S. to have a Unique Device Identifier (UDI) unless FDA grants an exception or alternative. The UDI should be placed on the device label and on the device packages. If the device is intended to be used more than once and reprocessed between uses, the UDI should also be placed on the device itself.

A UDI is a numeric or alphanumeric code that consists of two parts: a device identifier (DI) and a production identifier (PI). The DI is fixed and mandatory for all UDIs. It identifies the labeler and the specific version or model of a device. The PI is a conditional, variable portion of a UDI that identifies one or more of the following if included on the label:

  •     The lot or batch number
  •     The serial number
  •     The expiration date
  •     The date manufactured
  •     The distinct identification code for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

Class I devices do not require the PI portion of a UDI.

UDIs must be created by an FDA-accredited issuing agency. FDA has accredited three agencies to date: GS1 in New Jersey, HIBCC in Arizona, and ICCBBA in California. Once created, the labeler should provide the UDI in both human readable (plain text) and machine readable (AIDC) format. In most cases, the labeler is the device manufacturer, but specifically the labeler is 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.

Certain changes to devices will require a new DI. CFR § 830.50(a) states that “whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.” The labeler is responsible for deciding whether a change to a device constitutes a new version or model.

The labeler of devices bearing a UDI will be required to submit certain information to the Global Unique Device Identification Database (GUDID). The GUDID will be a publicly searchable database containing important identification information about every device with a UDI, but will not contain any information that could identify a patient.

The compliance dates for the UDI final rule begin this September, with class III medical devices leading the way. Other device types will follow in subsequent years through 2020. Not all medical devices will require a UDI, and a labeler may request an exception for devices that do. General exemptions include, but are not limited to:

  •     Devices used solely for research, teaching, or chemical analysis and not intended for clinical use
  •     Individual, single-use devices distributed in single packaging
  •     Custom and investigational devices
  •     Veterinary devices not intended for man
  •     Devices held by the National Strategic Stockpile

Class I devices in particular are exempt entirely from UDI requirements if FDA has exempted them from the good manufacturing requirements of 21 CFR 820. Class I devices that contain a Universal Product Code (UPC) on their labeling and packages are deemed to meet all UDI labeling requirements, but the labelers of such devices are still required to submit data to the GUDID.

For questions about FDA UDI regulation or for assistance determining how UDI regulation affects a specific product, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations.

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David Lennarz

Liviana Callahan
since: 08/2010
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