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Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

  • Thread starter Kevin Randall, RAC
  • Start date

Kevin Randall, RAC

· Right now the UDI rule is a pre-publication “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week.
· Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage.

· All devices [201(h) of the Act] will require UDI except:
- Those for purchase at retail (except prescription devices)
- Class 1 GMP-exempt
- Certain single-use class 1 devices not intended for individual sale
- Devices solely for research, teaching, or chemical analysis
- Custom, investigational, veterinary, and export-only devices
- Strategic Nat’l Stockpile devices
- Certain sec. 514 performance-standard devices
- Combination-product device-constituents that can’t be used apart from the combination
- Single-use members of convenience kits

· Class 1, 2, and 3 devices must comply by 5 years, 3 yrs, or 1 yr, respectively, after UDI final rulemaking (exception noted below).

· Shipping containers don’t need to display UDI.

· UDI’s must appear on the label and “package” (per UDI-rule definition).

· UDI’s shall have two parts: 1) Device Identifier [mandatory, fixed part identifying the labeler and the “version/ model” (special definition)]; and 2) Production Identifier (variable part for lot, expiry, etc.) when such variables are included on the label.

· Class 1 device UDI’s don’t require a Production Identifier.

· Each UDI must have a plain-text form AND a form based on AIDC technology. If the AIDC form is not conspicuous, then the label must display a special symbol.

· 2 years after the aforementioned phase-in dates, and within certain parameters, the UDI must also permanently appear DIRECTLY ON devices that are a) implantable; b) reusable and must be sterilized before each use; or c) stand-alone software.

· Each device “version/model” must bear a unique UDI. This is driven, among other things, by the fixed quantity of devices in a “package”.

· As currently worded, the proposed rule prohibits labelers from autonomously generating UDI (which may be unique for each unit or lot). Instead, EVERY UDI shall be issued by the FDA, or an FDA-accredited agency. This could have a significant operational impact on labelers, so I encourage readers to think carefully about this during the 120-day comment period.

· Dates on labels must now conform to the following format (today’s date for example): JUL 6, 2012

· UDI format must meet the criteria defined, as applicable, by a) ISO/IEC 646:1991; b) ISO/IEC 15459-2:2006(E); c) ISO/IEC 15459-4:2008; and d) ISO/IEC 15459-6:2007.

· Using various procedures, labelers must submit certain UDI data to FDA for posting in FDA’s online public “GUDID” (Global Unique Device Identification Database).

· GMP: The UDI shall be recorded on device history, complaint, and service records. Label inspection/release shall verify the correct UDI on labels.

· MDR’s & part 806 reports shall reflect the UDI of the subject device.

· Market-status updates in PMA periodic reports shall include UDI Device Identifiers (certain legacies excluded).

· Other UDI topics addressed by the rule include those related, but not limited to, combination products, convenience kits, voluntary UDI, change control, discontinuation of NHRIC and NDC numbers, and others.

Hope this helps,

Kevin Randall, RAC (U.S., CAN, EU)
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Involved In Discussions
Any ideas if we will be able to propose existing identifiers to the organization issuing the UDI? It would be advantageous to propose existing device identifiers (model numbers), rather then adopt a whole different set of device identifiers issued by an agency.

Also, it is not clear to me reading the UDI, how to comply with the direct marking rule for small medical devices. There does not apprear to be any provision to exempt devices that are too small to allow for a legible UDI.


There does not apprear to be any provision to exempt devices that are too small to allow for a legible UDI.
For implantables in particular, my understanding is that there is no intent to allow exemptions. Every implantable, no matter its size or characteristics, will have to be marked somehow.


I appreciate that any use of a laser marking procedure may raise both mechanical and biocompatibility concerns, but that's where I'd think our people would start if it were our product.

Laser marking via microablation of plastic or metal surfaces can be very small, limited mostly by microsurface cleanliness and smoothness and ultimately by atomic considerations. "Reading" would be with microscope techniques.

I don't know of any commitment in the UDI project that the resulting markings will be unaided-eye-readable. The point of marking implantables, as I understand what's been explained to date, is to permit positive identification of a device at time of implantation and if need be at time of explantation. In the case of a small device used in microsurgery or scope/catheter procedures, whatever identification support technology is needed may be brought to bear.


Involved In Discussions
21CFR801.15 describes requirements for prominence of required label statements. It states "smallness or style of type ins shuch word, statement, or information appears, insufficient background contract, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.

I think the point of this part of the regulation was to prevent hiding things in the "fine print". I did not see anything in the proposed UDI rule that exempted direct marking from this requirement. Maybe, I missed something in the lengthy document. We make orthopedic screws for spinal fixation. I think that to comply the direct marking requirement, the print would have to be microscopic.


What would be the best recommendation to mark an endoprosthesis, I mean for the use of AIDC technique? Bar code?


You can refer to "Request for Modification of Unique Device Identifier Labeling Requirements for Devices That Have Small Labels" if you haven't already found it.
Find it at the federalregister(dot)gov under /articles/2013/09/24/2013-23059/unique-device-identification-system#h-30


After spending the day reviewing articles and online information regarding the UDI process I have to say thanks to Kevin for the information on his blog and posts on the cove.
Can anyone answer a few questions please?
1. Seems like the UDI number is NOT the part number of the product, correct?
2. Is there anything stopping us from continuing to use our current 3d barcode which allows alphanumeric data? We have scanned products for traceability for over 10 years and have a lot invested in the process and equipment.
3. Regarding the UDI class I exempt items, are these the same devices listed as exempt for 510k?.
4. Would the UDI categories be linked to the FDA Product Code classifications?
Maybe it is too soon to ask for answers but...
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