Unique Device Identification (UDI)

On 24th September 2013, FDA published a final rule in the Federal Register to implement a US Unique Device Identification System for medical devices. Ortho Solutions supports the FDA’s Unique Device Identification (UDI) regulations and GS1 standards for both product identification and utilisation in e-commerce transactions.

This effort matches a worldwide regulatory effort to institute a medical device identification system to improve several key post-market activities:

  1. Reduce medical errors resulting from device misidentification.
  2. More accurate adverse event reporting by making device identification easier.
  3. Allow FDA, healthcare providers and industry to extract useful adverse event report information more rapidly to take appropriate, better-focused, corrective action.
  4. Standardise medical device label dates to be understood clearly by device users.
  5. Help establish a secure global supply chain and prevent counterfeiting.

Ortho Solutions is adhering to the compliance timelines (Table 1) and expectations as specified by the FDA’s final rule on UDI, with all U.S. sold products having a GTIN assigned, updated labels, and (where required) direct part marking changes completed by the FDA timeline for newly manufactured products . UDI implementation is ongoing and will continue over the next several years, resulting in a rapidly searchable database and tracking system with global significance.

Compliance date Requirement
1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014. Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015 ) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining device that is required to be labelled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labelled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (September 24, 2016) Class III devices required to be labelled 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. § 801.45.
The labels and packages of class II medical devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labelled with a UDI must be submitted to the GUDID database. § 830.300.
5 years after publication of the final rule (September 24, 2018) A class II device that is required to be labelled 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. § 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labelling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labelled with a UDI must be submitted to the GUDID database. § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule (September 24, 2020) Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labelled with a UDI, must a bear 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. § 801.45.
Compliance dates for all other provisions of the final rule. Except for the provisions listed in this table, FDA requires full compliance with the final rule as of the effective date that applies to the provision.

Ortho Solutions Product Labels – What is changing?

You will start to see new GS1 barcode labels on Ortho Solutions products. To support the UDI initiative, Ortho Solutions are updating our product labels to include barcodes that conform to standards created by GS1. GS1 develops and maintains standards for supply and demand chains across multiple sectors, including the healthcare industry.

The FDA accredited GS1 as an issuing agency to assign Unique Device Identifiers (UDIs). GS1 provides the UDIs and sets the rules for how barcodes containing those UDIs appear on packaging. As a product’s unique identifier, or Global Trade Item Number (GTIN) becomes available, it will be appear on labels, the downloadable cross-reference sheet, drawings, delivery and packing notes and other documentation.

Most product labels will bear a Data Matrix (2D) barcode providing automatic identification data capture (AIDC) and a human readable text of the product’s unique identifier, or Global Trade Item Number (GTIN).

The process will be a rolling change, and Ortho Solutions products will appear in the market with both format labels (depending on the date they were released to the market). Customers may continue to use the product catalog numbers to place orders.

Old Label Format New Label Format
 old-label new-label

Summary of Changes:

“Use By” Date format changed:

  • From: YYYY-MM To: YYYY-MM-DD

GS1 Matrix Barcode Information:

  • (01) GTIN#
  • (17) Expiration Date (YYMMDD)
  • (10) Lot Number

Non-Sterile implant and instrument sets – How will UDI be achieved?

Whilst the objective of the UDI rule is to establish a system for the adequate identification of medical devices through distribution and use, the FDA realises there are unique complexities and challenges for conveying UDI’s at the point of use for certain devices.

On March 22nd, 2016 the FDA issued a letter clarifying their position on non-sterile re-processable implant and instrument sets.

The FDA, in its official letter regarding non-sterile implants on instrument sets state “For non-sterile implantable devices not covered by the general exception in 21 CFR 810.30 (d) (i.e., Class II and Class III devices), FDA understands with current technology there are cases in which size, geometry, material specifications, and/or other markings required for patient safety may not permit direct marking with production information, and therefore the entire UDI may not be available at point of use. In such cases, making the DI alone available at the point of use for non-sterile implantable devices meets the objectives of the UDI Rule”. – This ruling is applied in conjunction with a cross-reference tool.

View our UDI Cross Reference table

UltOS™ Foot Plating System UDI Cross Reference Sheet Effective Date September 20th 2016, DCR 450

UltOS UDI Cross Reference Sheet