UDI Exceptions and Alternatives
October 19, 2022 Update: UPC Alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023. UDI Stakeholders: to help you understand what the expiration of these alternatives means for you, please read UPC Alternative UDI-A160001 and UDI-A160002 Questions and Answers.
The UDI rule provides a method for labelers to request exceptions and alternatives to UDI requirements.
On this page:
- Exceptions and Alternatives Granted by FDA
- Exceptions and Alternatives - General Information and How to Request
- General Questions and Answers on Time-Limited Alternatives
Exceptions and Alternatives Granted by the FDA
Under to 21 CFR 801.55(c), any labeler may make use of an exception or alternative granted under § 801.55, provided that such use satisfies all safeguards or conditions that are part of the FDA exception or alternative decision.
Labelers should refer to the information in the table below, especially in the "FDA Decision" column, to determine if an exception or alternative listed may apply to their situation. Labelers may document the applicability and use of an exception/alternative in the device master record (DMR) as part of the labeling specifications required under 21 CFR 820.181(d) for each respective device, along with a copy of the applicable exception or alternative decision.
| FDA UDI Exception or Alternative Number | Summary | FDA Decision | Expiration Date of Exception or Alternative | Date of Posting |
|---|---|---|---|---|
| UDI-A160001* | UPC - multiple product codes | Decision | 2023-09-24 | 2021-07-29 |
| UDI-A160002* | UPC - contact lens care | Decision | 2023-09-24 | 2021-07-29 |
| UDI-A170001 | Sterile inventory; 3-year exception; 21 CFR 801.30(a)(1) |
Decision | 2024-09-24: Class III; 2025-09-24: I/LS/LS; 2026-09-24: Class II |
2019-04-29 |
| UDI-E140001 | Soft (hydrophilic) contact lenses | Decision | One year after FDA: 1) develops and fully integrates the Technical Solution into the GUDID production system, 2) provides any necessary updated technical specifications to affected labelers, and 3) notifies industry that the extension will expire, through emails to industry, communication via trade associations, and via the UDI website. |
2017-03-30 |
* For more information, read UPC Alternatives UDI-A160001 and UDI-A160002 Questions and Answers.
Version 1.8: June 22, 2022
| FDA Product Code | FDA Product Code Name | Regulation (21 CFR) |
|---|---|---|
| EBO | Over the Counter Denture Repair Kit | 872.3570 |
| EBP | Reliner, Denture, Over the Counter | 872.3560 |
| EMA | Cement, Dental | 872.3275 |
| FLK | Thermometer, Clinical Mercury | 880.2920 |
| FLL | Thermometer, Electronic, Clinical | 880.2910 |
| FMF | Syringe, Piston | 880.5860 |
| FMI | Needle, Hypodermic, Single Lumen | 880.5570 |
| FRO | Dressing, Wound, Drug | N/A |
| GZJ | Stimulator, Nerve, Transcutaneous, for Pain Relief | 882.5890 |
| HEB | Tampon, Menstrual, Unscented | 884.5470 |
| HHE | Cup, Menstrual | 884.5400 |
| HHW | Pessary, Vaginal | 884.3575 |
| HIL | Tampon, Menstrual, Scented, Deodorized | 884.5460 |
| HIS | Condom | 884.5300 |
| ILY | Lamp, Infrared, Therapeutic Heating | 890.5500 |
| KKO | Ring, Teething, Fluid-Filled | 872.5550 |
| LBH | Varnish, Cavity | 872.3260 |
| LCX | Kit, Test, Pregnancy, hCG, Over the Counter | 862.1155 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 862.3870 |
| LFD | Saliva, Artificial | N/A |
| LKY | Device, External Penile Rigidity | 876.5020 |
| LPN | Accessories, Soft Lens Products | 886.5928 |
| LRR | First Aid Kit with Drug | N/A |
| LRX | Case, Contact Lens | 886.5928 |
| LTZ | Condom with Nonoxynol-9 | 884.5310 |
| LYL | Accessories, Solution, Ultrasonic Cleansers for Lenses | 886.5928 |
| MNW | Analyzer, Body Composition | 870.2770 |
| MSC Added 06/23/2022 |
Barrier, STD, Oral Sex | 884.5300 |
| MOL | Condom, Synthetic | 884.5300 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 886.5918 |
| NUC | Lubricant, Personal | 884.5300 |
| NUH | Simulator, Nerve, Transcutaneous, Over-the-Counter | 882.5890 |
| OBR | Mouthguard, Over-the-Counter | N/A |
| OHT | Light Based Over-the-Counter Hair Removal | 878.4810 |
| PEB | Lubricant, Personal, Gamete, Fertilization, and Embryo Compatible | 884.5300 |
| POV | Semen Analysis Device | 864.5220 |
| QRZ Added 06/22/2022 |
External Condom for Anal Intercourse or Vaginal Intercourse | 884.5305 |
FDA Product Codes for UDI Alternative UDI-A160001 - Document History
| Version | Date | Change |
|---|---|---|
| 1.0 | August 19, 2016 | Original |
| 1.1 | September 6, 2016 | Added the following FDA Product Codes: FLK, FLL, LPN, LRX, LYL, and MRC |
| 1.2 | October 5, 2016 | Added the following FDA Product Code: MNW |
| 1.3 | November 30, 2016 | Added the following FDA Product Code: ILY |
| 1.4 | January 11, 2017 | Added the following FDA Product Code: POV |
| 1.5 | January 4, 2018 | Added the following FDA Product Code: LFD |
| 1.6 | June 28, 2018 | Added the following FDA Product Code: HHE |
| 1.7 | November 5, 2021 | Added the following FDA Product Codes: GZJ and OBR |
| 1.8 | June 22, 2022 | Added the following FDA Product Codes: MSC and QRZ |
Version 1.0: October 5, 2016
| FDA Product Code | FDA Product Code Name | Regulation (21 CFR) |
|---|---|---|
| LPN | Accessories, Soft Lens Products | 886.5928 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 886.5918 |
FDA Product Codes for UDI Alternative UDI-A160002 - Document History
| Version | Date | Change |
|---|---|---|
| 1.0 | October 5, 2016 | Original |
| FDA Product Code | FDA Product Code Name | Regulation (21 CFR) |
|---|---|---|
| LPM | Soft (hydrophilic) Contact Lens (extended wear) - Class III Device | 886.5925(b)(2) |
| NCZ | Soft (hydrophilic) Contact Lens (for color vision deficiency) - Class II Device | 886.5925(b)(1) |
| NIC | Soft (hydrophilic) Contact Lens (for reading discomfort) - Class II Device | 886.5925(b)(1) |
| LPL | Soft (hydrophilic) Contact Lens (daily wear) - Class II Device | 886.5925(b)(1) |
| MVN | Soft (hydrophilic) Contact Lens (disposable) - Class II Device | 886.5925(b)(1) |
Exceptions and Alternatives - General Information and How to Request
A labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device.
In response to labeler requests or on our own initiative, the FDA may grant an exception or alternative if an exception is appropriate because the requirements of 21 CFR 801 Subpart B are not technologically feasible, or that an alternative would provide for more accurate, precise, or rapid device identification than the requirements of 21 CFR 801 Subpart B or would better ensure the safety or effectiveness of the device that would be subject to the alternative. If the FDA grants an exception or alternative, we may include safeguards or conditions deemed appropriate to ensure the adequate identification of the device through its distribution and use. The FDA is making its decisions on labeler requests for exceptions and alternatives available at "FDA Decisions."
In order to establish a system to adequately identify medical devices through distribution and use, the FDA expects that the labels of almost all devices are capable of bearing and should in fact bear a UDI on the label, unless excepted under 21 CFR 801.30.
Under 21 CFR 801.55(c), the FDA will consider granting requests for an exception from a UDI requirement if the requirement is not technologically feasible. We expect that such situations will be rare. The FDA does not consider exception requests that are based on reasons other than technological infeasibility (including, but not limited to, financial burden or claims of few or no adverse events).
Labelers may consider the following to address issues of inadequate label space, or unique packaging that may create challenges to having the device label bear its UDI in both easily readable plain-text and AIDC forms:
- Remove or minimize information on the label that is not required under 21 CFR Part 801 (or 21 CFR 809.10, if your device is an in vitro diagnostic product), or otherwise required by regulation or order. See 21 CFR 801.15 for more information on prominence of required label statements.
- Increase the size of the label or modify the label e.g., move label to a flatter location on the immediate container) to accommodate the UDI.
- Use a smaller form of AIDC technology or split the AIDC form into multiple segments. The easily readable plain-text UDI may also be split into multiple segments.
If the approaches described above cannot be used to address a labeler's concerns, the labeler may consider submitting a request for an alternative under 21 CFR 801.55 to add an overwrap that would bear the UDI or place another label bearing the UDI elsewhere on the packaging.
- Submit a UDI exception/alternative inquiry using the link below. In response, the FDA UDI Help Desk will email instructions for requesting an exception from or alternative to a UDI requirement. If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was diverted to your spam/junk folder, please adjust your filter to recognize the UDI Help Desk as a contact.
- Review the instructions and include the necessary information in your request.
- Submit the request as indicated in the instructions. An FDA UDI Help Desk Analyst will respond to your request.
Submit New Exception or Alternative Request
According to 21 CFR 801.55(a), when submitting your request for an exception or alternative you must:
- Identify the device or devices that would be subject to the exception or alternative;
- Identify the provisions of 21 CFR 801 Subpart B that are the subject of the request for an exception or alternative;
- If requesting an exception, explain why the requirements of 21 CFR 801 Subpart B are not technologically feasible;
- If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of 21 CFR 801 Subpart B or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative;
- If known, provide the number of labelers and the number of devices that would be affected if the requested exception or alternative were granted; and
- Provide other requested information needed to clarify the scope and effects of the requested exception or alternative.
General Questions and Answers on Time-Limited Alternatives
Since the publication of the UDI Rule in 2013, the FDA has granted time-limited alternative requests while labelers established or finalized internal processes and procedures needed to comply with UDI requirements. Below, we provide information about what it means for devices when the FDA does not extend a time-limited alternative.
Q1: What does it mean when a time-limited alternative expires?
A: Once a time-limited alternative expires, devices previously using the alternative must comply with applicable requirements of the UDI Rule, including adding the UDI to the device label and updating data in the Global Unique Device Identification Database. The FDA recommends consulting available guidance documents, in addition to the UDI Rule, to help understand applicable requirements.
The FDA does not object to the continued use of the alternative for finished devices that are manufactured and labeled prior to September 24, 2023. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.
Q2: If an alternative has not expired, can I still submit a request to use the alternative for products not currently under the specified alternative?
A: You may continue to submit requests for new products to be added to an alternative that has been granted before the alternative expires. Such devices may use the alternative until it expires.
For more information, please read Universal Product Codes (UPC) Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions.