Medical Device News: FDA's Plan for UDI Regulation

August 7, 2012

By Pam Davol, Clinical & Regulatory Project Manager

What is the FDA’s Unique Device Identification System?

The Unique Device Identification (UDI) System is a new regulation to be imposed by the FDA that requires the labeling of medical devices and medical device constituents (i.e. device components of combination products) to bear a unique identifier, which will adequately identify the device through distribution and use, and may include information on the lot or serial number.

Who will be affected by the new UDI regulation?

The UDI regulation applies to medical device manufacturers.

To which devices does the new UDI regulation apply?

The UDI regulation applies to Class I, Class II and Class III devices manufactured for clinical use or sale in the United States. Several general exemptions apply;

How does the UDI System work?

The FDA will maintain the Global UDI database to which manufacturers will submit detailed information about the individual product identified.

What information is the UDI code required to contain?

Exemptions from the UDI regulation:

  • Class I devices are not required to have production identifiers in UDI, only a Device Identifier (see below).
  • Devices, other than prescription devices, made available for purchase at retail establishments are exempt from the UDI System regulation.
  • GMP-exempt Class I devices are exempt from the UDI System regulation.
  • Individual class I, single-use devices, all of a single version or model, that are distributed together in a single device package, which are not intended for individual sale.
  • The UDI is on the package.
  • Devices used for research, teaching, or chemical analysis, and which are not intended for any clinical use are exempt from the UDI System regulation.
  • Custom devices within the meaning of 21 CFR 812.3(b) are exempt from the UDI System regulation.
  • Investigational devices regulated under 21 CFR 812 are exempt from the UDI System regulation
  • Veterinary devices not intended for human use are exempt from the UDI System regulation.
  • Devices intended for export from the US are exempt from the UDI System regulation.
  • Devices held by the Strategic National Stockpile are exempt from the UDI System regulation.
  • Devices for which FDA has established a performance standard and has included an UDI exception are exempt from the UDI System regulation.
  • Shipping containers are exempt from the UDI System regulation.
  1. An international standards organization [i.e. GS1, HIBCC] will issue a manufacturer prefix or labeler code to each manufacturer to develop its own UDI code.
  2. Each manufacturer must create and maintain its own UDI code according to ISO-15459.
  3. The manufacturer takes that code and creates and applies a unique UDI code for all levels of packaging down to the lowest level of patient use of that particular product.
  4. The UDI code must be human readable and encoded in a form of automatic identification technology. (Note: FDA does not indicate any specific technology.)
  5. The default location for the UDI code is the device label.
  6. The manufacturer will be required to apply UDI code “direct part marking” to the following devices:
    1. Long-term (>30 day) implantable devices;
    2. Devices that are intended to be used more than once and sterilized between patient use (i.e. reusable surgical instruments); and
    3. Stand-alone software

Detailed information to be submitted to the UDI Global database:

  • Device Identifier Type/Code [GTIN, HIBCC] (see next question)
  • Make/model; Brand/Trade Name
  • Clinically relevant size d. Device version/model number (or reference number)
  • Unit of Measure/Packaging level/quantity
  • Controlled by – Lot and/or Serial Number; Exp. Date
  • Labeler contact name, phone, email
  • GMDN (General Medical Device Nomenclature) Classification code/term
  • Whether packaged sterile
  • Whether contains latex
  • FDA premarket authorization (510k, PMA)
  • Listing number

There are two parts to the UDI code: the Device Identifier and the Production Identifier.

The Device Identifier identifies a specific manufacturer’s version, make or model of a device, and it is analogous to an NDC number or UPC code. This information is

The Production Identifier provides the control information for the device such as the lot number, expiration date, a serial number or some other identifying information used by the manufacturer. The UDI regulation requires additional information if the label includes an expiration and/or manufacture date;

When will manufacturers need to implement the new UDI System requirements?

Additional information required if a label includes an expiration and/or manufacture date:

  • The date to be presented as Month Day, Year (JAN 1, 2012)
  • All dates must include a day (JAN 2012 not allowed)
  • The month shown as a three letter abbreviation in capital letters: e.g., JAN, FEB
  • The day is a number from 1-31
  • The year is a four digit number

Requirements for implementation will be based on the device premarket risk class as follows:
Note: UDI code requirements do not apply to devices that are already in distribution at the time these requirements go into effect.

Class III (ex. implants)– 12 months after final rule published
Class II (ex. equipment) – 36 months after final rule published
Class I (ex. disposables) – 60 months after final rule published
Direct part marking requirements are effective 2 years after class effective date

How do the new UDI system requirements apply to combination products having a device constituent?

A UDI code is required for each device and each constituent of a combination product if:
Do the new UDI System requirements apply to device kits?

  • The primary mode of action of the combination product is the device (i.e. typically in cases in which the combination product is regulated or would be regulated by CDRH), unless…
  • the constituent parts are either physically, chemically or otherwise combined with the other constituent parts, such that one can’t use them without each other, in which case…
  • each constituent part does not need its own UDI, but the combination product itself would still need its own UDI.

Yes, UDI regulations also apply to medical device kits.

If a manufacturer is distributing a group of medical devices as a surgical kit, the kit itself would need its own UDI and each part, or each device within that kit would also need its own UDI. The exception would be if any devices within the kit are intended only for single use, then that single-use device would not need its own UDI.

What about those devices that are primarily dispensed through pharmacies, such as diabetes care products, which to date have carried either NDC (National Drug Code) or NHRIC (National Health Related Item Code) numbers. Do the UDI code requirements apply?

As the effective date comes into play for their respective class of device, manufacturers will no longer be allowed to use these national numbering systems. The FDA will be phasing out the use of NDC or NHRIC numbers completely for all medical devices with the implementation of the UDI.

To learn more about FDA’s UDI System.