The UDI rule provides a method for labelers to request exceptions, alternatives, and time extensions to UDI requirements.
UDI Enforcement Discretion Applying to Class I and Unclassified Devices1,2
FDA has issued a guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as set out in Figure 1 below.
|Type of Device||FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before||FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before:|
|Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018||September 24, 2020||September 24, 2022|
|Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018||September 24, 2021||September 24, 2022|
1 Does not apply to class I or unclassified implantable, life-supporting or life-sustaining devices; labelers of these devices must already be in compliance with UDI requirements. Class I CGMP-exempt devices are excepted from UDI requirements. 21 CFR 801.30(a)(2).
2 Consistent with 21 CFR 801.30(a)(1), finished class I and unclassified devices manufactured and labeled before September 24, 2018, are excepted from the UDI labeling and GUDID submission requirements by regulation until September 24, 2021.
For more information, see "Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices – June 2, 2017".
This guidance also describes the FDA's direct mark compliance policy. The FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for class III, LS/LS, and class II non-sterile devices, requiring a direct mark, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory, provided the device bears a non-UDI direct mark and the labeler has developed a method by which, using the non-UDI mark, the UDI may be made available. For more information on the policies that apply to certain devices subject to UDI direct marking, see Figure 2, below.
Resources for policies that apply to certain devices subject to UDI Direct Marking
General exceptions from the requirement for the label of a device to bear a unique device identifier (§ 801.30)
Under § 801.30, the UDI rule provides general exceptions from UDI labeling requirements to certain categories of devices. A device within one or more of these exceptions is not required to bear a UDI. A labeler of a device identified in § 801.30 is not required to request an exception from FDA.
Request for an exception from or alternative to a UDI requirement (§ 801.55)
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 any 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."
Considerations for Labelers
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 unique device identifier (UDI) on the label, unless excepted under § 801.30.
Under 21 CFR 801.55(c), 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. FDA does not consider exception requests that are based on reasons other than technological infeasibility (including, but not limited to, financial burden, a claimed low rate of adverse events, or a claim that the product is somehow unique such that adverse events do not occur).
Labelers may consider the following to address issues of inadequate label size 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 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.
To request an exception from or alternative to the requirements of 21 CFR 801 Subpart B:
- Submit a UDI exception/alternative inquiry 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 sent 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.
Help Desk Exceptions/Alternatives Inquiry
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 we grant the requested exception or alternative; and
- Provide other requested information needed to clarify the scope and effects of the requested exception or alternative.
UDI Time Extensions
The FDA requires device labelers to comply with UDI requirements according to the dates established in conjunction with the UDI Rule. The UDI label and GUDID submission compliance date for class II devices that are not considered implantable, life-supporting, or life-sustaining (I/LS/LS) was September 24, 2016.
The FDA believes the phased implementation schedule outlined in the final UDI Rule has given labelers of class III, I/LS/LS, and class II devices adequate time to comply with all applicable UDI requirements by September 24, 2016. We expect all labelers to be making diligent efforts to fulfill their UDI obligations. Labelers with questions about UDI implementation may contact the FDA UDI Help Desk.
The FDA has granted labelers of particular types of devices an extension of certain UDI compliance dates when the FDA has determined that an extension would be in the best interest of the public health. Those extension letters are listed below.
Continued use of FDA labeler code (§ 801.57)
In order to conform to changes made under the Unique Device Identification (UDI) final rule (UDI Rule), the FDA has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices. Prior to the UDI Rule, device manufacturers and distributors who wished to use the NHRIC system for unique product identification could apply to the FDA for a labeler code, which is the first segment in the two-segment NHRIC number. Since the publication of the UDI Rule, however, FDA ceased issuing new FDA labeler codes for medical devices.
The use of NHRIC and NDC numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. On the date a medical device must bear a UDI on its label, any NHRIC or NDC numbers assigned to the device are rescinded and may no longer be provided on the device label or package. If a device is not required to have a UDI on its label, any NHRIC or NDC number assigned to it is rescinded and may no longer be on the device label or package after September 24, 2018. The Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff, issued on August 30, 2016, describes FDA's intent not to enforce the prohibition against providing NHRIC and NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.
The UDI Rule permits a labeler to request continued use of a previously assigned FDA labeler code under a system for the issuance of UDIs provided that such use of the FDA labeler code is consistent with the framework of the issuing agency that operates that system, as described under 21 CFR 801.57(c). The Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Guidance for Industry and Food and Drug Administration Staff, describes FDA's intent to consider such requests until September 24, 2021. Such requests should be submitted no later than September 24, 2021.
To request continued use of an FDA-assigned NHRIC or NDC labeler code:
- Submit a continued use labeler code inquiry below. The FDA UDI Help Desk will email instructions for requesting the continued use of an FDA-assigned labeler code. If you do not receive an immediate reply in your inbox, please check the spam/junk folder. If the email was sent 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.
Help Desk Continued Use of FDA Labeler Code Inquiry
According to 21 CFR 801.57(c), when submitting your request for continued use of an FDA-assigned labeler code you must provide:
- The name, mailing address, email address, and phone number of the labeler who is currently using the labeler code.
- The owner/operator account identification used to submit registration and listing information to FDA's Unified Registration and Listing System (FURLS). Please note this is different than the owner/operator number.
- The FDA labeler code that the labeler wants to continue using.
FDA Exception/Alternative Decisions
Under § 801.55, 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. For more information on requesting a UDI exception or alternative, see the Exceptions/Alternatives tab.
The FDA is making its decisions on labeler requests for exceptions and alternatives available to the public on this web page. According to § 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 § 820.181(d) for each respective device, along with a copy of the applicable exception/alternative decision.
|Keywords||FDA Product Codes||Request||FDA Decision||Decision Category||Expiration Date
|Date of Posting|
|UDI-A160001||UPC||[Product Codes]||N/A||[Decision]||Granted with Conditions||2021-09-24||2016-08-19|
|UDI-A160002||UPC||[Product Codes]||N/A||[Decision]||Granted with Conditions||2021-09-24||2016-10-05|
21 CFR 801.30(a)(1)
|N/A||N/A||[Decision]||Granted with Conditions||2024-09-24: Class III;
2026-09-24: Class II
UDI Extension Letters
- Letter to Manufacturers of Drug/Device or Biologic/Device Combination Products assigned to Center for Drug Evaluation and Research (CDER) for Premarket Review - August 9, 2018 (PDF - 93KB)
- Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices - June 2, 2017 (PDF - 80KB)
- UDI Extension Letter to Soft Contact Lens Labelers - March 30, 2017 (PDF - 66KB)
- UDI Extension Letter to Rigid Gas Permeable Contact Lens Manufacturers - September 22, 2016 (PDF - 128KB)
- UDI Extension Letter to Device Labelers - September 6, 2016 (PDF - 163KB)
- UDI Extension Letter to Soft Contact Lens Labelers - October 6, 2015 (PDF - 133KB)
- UDI Letter to IOL Labelers re: GUDID Submissions - July 10, 2015 (PDF - 58KB)
- UDI Extension Letter to Implant Labelers - November 19, 2014 (PDF - 119KB)
- UDI Extension Letter to Class III Contact Lens and Intraocular Lens Labelers - August 15, 2014