Contains Nonbinding Recommendations
Unique Device Identification: Policy 
Regarding Compliance Dates for Class 
I and Unclassified Devices, Direct 
Marking, and Global Unique Device 
Identification Database Requirements 
for Certain Devices
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on July 25, 2022
This document supersedes Unique Device Identification: Policy Regarding 
Compliance Dates for Class I and Unclassified Devices and Certain Devices 
Requiring Direct Marking, Immediately In Effect Guidance for Industry and 
Food and Drug Administration Staff, issued July 1, 2020.
For questions about this document regarding CDRH-regulated devices, contact the FDA UDI Help 
Desk, 301-796-5995, email: GUDIDSupport@fda.hhs.gov. For questions about this document 
regarding CBER-regulated devices, contact the Office of Communication, Outreach, and 
Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
    
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.  
Identify all comments with the docket number FDA-2017-D-6841. Comments may not be acted 
upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 17029 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 240-402-8010, 
by email, ocod@fda.hhs.gov, or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances.  Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ............................................................................................................................. 1
II.  Background ............................................................................................................................. 3
III.  Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission 
Requirements for Class I and Unclassified Devices ....................................................................... 6
Compliance Policy for Standard Date Formatting and UDI Labeling Requirements for 
Class I and Unclassified Devices................................................................................................6
Compliance Policy for GUDID Submission Requirements for Class I Devices.............6
Compliance Policy for GUDID Submission Requirements for Unclassified Devices....8
IV.  Policy for Direct Mark of Certain Devices .......................................................................... 9
A.  Class III, LS/LS, and Class II Non-Sterile Devices Manufactured and Labeled Prior to 
the Established Direct Mark Compliance Date That Remain in Inventory ................................ 9
B.  Class I and Unclassified Devices ................................................................................... 10 Contains Nonbinding Recommendations
Unique Device Identification: Policy 
Regarding Compliance Dates for Class 
I and Unclassified Devices, Direct 
Marking, and Global Unique Device 
Identification Database Requirements 
for Certain Devices 
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I.  Introduction
FDAs unique device identification system (UDI system) is designed to adequately identify 
devices through distribution and use.1Its requirements were designed to be phased in over seven 
years according to established compliance dates based primarily on device classification.
The compliance dates established for class I and unclassified devices, other than implantable, 
life-supporting, or life-sustaining (I/LS/LS) devices2are:
 September 24, 2018, for the following requirements:
o  Standard date formatting (21 CFR 801.18),
o  Labeling (21 CFR 801.20, 21 CFR 801.50), and
1 The final rule establishing the UDI system was published September 24, 2013 (78 FR 58786).
2 Section 519(f) of the Federal Food, Drug, and Cosmetic Act requires implementation of FDAs UDI system 
regulations for I/LS/LS devices within two years of finalizing those regulations. I/LS/LS devices were required to 
comply with labeling, direct mark, and GUDID submission requirements under 21 CFR 801.20, 801.45, 801.50, 
and 830.300, as well as the standard date format requirement under 21 CFR 801.18, by September 24, 2015, 
unless an exception or alternative applied. See 78 FR at 58815-58816.
1 Contains Nonbinding Recommendations
o  Global Unique Device Identification Database (GUDID) data 
submission (21 CFR 830.300); and
 September 24, 2020, for direct mark requirements (21 CFR 801.45).3
This guidance describes FDAs policies with regard to enforcement of these requirements for 
class I and unclassified devices,4 including the Agencys compliance policy regarding GUDID 
submission requirements under 21 CFR 830.300 for certain class I devices considered consumer 
health products. In addition, the guidance describes how a labeler of a class I device can 
determine whether its device is within the scope of that compliance policy.  
This guidance also reiterates FDAs direct mark compliance policy for class III, LS/LS, and class 
II devices that are non-sterile, 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 not LS/LS devices, that are non-sterile, that are manufactured and labeled prior 
to September 24, 2022, and that remain in inventory.
Throughout this guidance document, the terms we, us, and our refer to FDA staff 
from the Center for Devices and Radiological Health (CDRH) and the Center for Biologics 
Evaluation and Research (CBER). You and your refer to the labeler, as defined in 21 
CFR 801.3.
A portion of this guidance describing a 75-day extension of an existing FDA compliance policy 
is being implemented without prior public comment because the Agency has determined that 
prior public participation is not feasible or appropriate (section 701(h)(1)(C) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). FDA 
has determined that this approach presents a less burdensome policy that is consistent with public 
health. Although the portion of this guidance describing that policy is being implemented 
immediately, the guidance remains subject to comment in accordance with the Agencys good 
guidance practices. The remainder of the updates to this guidance are being implemented 
following the opportunity for public comment on FDAs draft guidance, Select Updates for 
Unique Device Identification: Policy Regarding Global Unique Device Identification Database 
Requirements for Certain Devices, issued October 14, 2021.
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited. The use of the word should in Agency 
guidance means that something is suggested or recommended, but not required.
3 See 78 FR at 58815-58816.
4 The compliance policies for class I and unclassified devices described in this guidance do not apply to I/LS/LS 
devices. Additionally, class I devices that FDA has by regulation exempted from the good manufacturing practice 
requirements are outside the scope of this guidance because such devices are excepted from UDI requirements (21 
CFR 801.30(a)(2)).
2 Contains Nonbinding Recommendations
II.  Background
On September 24, 2013, the FDA published a final rule establishing a UDI system designed to 
adequately identify devices through distribution and use (the UDI Rule).5 Phased 
implementation of the regulatory requirements set forth in that final rule is based on a series of 
established compliance dates based primarily on device classification, which range from 
September 24, 2014, to September 24, 2020.6
The UDI Rule requires a device to bear a unique device identifier (UDI) on its label and 
packages unless an exception or alternative applies (21 CFR 801.20), and special labeling 
requirements apply to stand-alone software regulated as a device (21 CFR 801.50). The UDI 
Rule also requires that data pertaining to the key characteristics of each device required to bear a 
UDI be submitted to FDAs GUDID (21 CFR 830.300). GUDID provides a repository of device 
safety information for FDA. Most of the information submitted to GUDID is also available to the 
public through AccessGUDID.7 AccessGUDID enables healthcare providers and patients to 
obtain useful safety information on specific device models, such as sterility requirements and 
MRI compatibility information. 
In addition, the UDI Rule added 21 CFR 801.18, which requires certain dates on device labels to 
be in a standard format. As explained in the preamble to the UDI Rule, FDA aligned the 
compliance date for standard date format requirements under 21 CFR 801.18 with the 
compliance date by which a device must bear a UDI on its label and packages under 21 CFR 
801.20 to avoid the need to make changes to a device label more than once to implement the 
requirements in the final rule.8 For devices that 1) must bear UDIs on their labels and 2) are 
intended to be used more than once and reprocessed between uses, 21 CFR 801.45 requires the 
devices to be directly marked with a UDI.9
The UDI system seeks to improve the identification of medical devices by making it possible to 
rapidly and definitively identify a device and certain key attributes related to a devices safe and 
effective use. Fully realizing the benefits of the UDI system depends on UDIs being integrated 
into data sources throughout our healthcare system, including in the supply chain, electronic 
health records, and registries. This requires UDI data to be of a high quality, such that all 
stakeholders in the healthcare community have sufficient confidence in the accuracy and 
completeness of that data.
In January 2018, FDA issued the initial version of this guidance document, Unique Device 
Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,10
5 78 FR 58786.
6 See 78 FR at 58815-58816.
7 Available at: https://accessgudid.nlm.nih.gov/ 
8 See 78 FR at 58795.
9 For more information on direct mark requirements under 21 CFR 801.45, see Unique Device Identification: 
Direct Marking of Devices (Direct Mark Guidance), available at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/unique- device-identification-direct-marking-devices.
10 83 FR 2057 (Jan. 16, 2018). This previous version of the guidance stated that for class I and unclassified devices, 
the Agency did not intend to enforce standard date formatting, UDI labeling, and GUDID data submission 
3 Contains Nonbinding Recommendations
which was superseded in November 2018 by the guidance, Unique Device Identification: Policy 
Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices 
Requiring Direct Marking,11 and then subsequently superseded in July 2020 by the guidance 
with the same title (hereafter referred to as 2020 UDI Compliance Policy Guidance).12
Throughout that time, FDA has been working with labelers on implementing UDI requirements 
and addressing policy and technical issues. The prior versions of this guidance reflected our 
belief that it was important to continue focusing our resources on addressing UDI 
implementation issues and data quality for higher risk devices. In addition, as described in the 
2020 UDI Compliance Policy Guidance, to the extent the policy articulated in that guidance 
helped labelers remain focused on public health needs related to Coronavirus Disease 2019 
(COVID-19), we believe it was further consistent with the public health.
As UDI implementation has progressed, FDA has gained further insight into the public health 
benefits and potential burdens of UDI requirements for class I devices, which generally pose the 
lowest risk. Many 510(k)-exempt class I devices are sold directly to consumers over-the-counter 
in brick-and-mortar and/or online stores. For purposes of this guidance, we refer to these devices, 
when they do not fall within one or more of the categories identified in section III.B.2, as 
consumer health products. These class I devices are also typically labeled with a Universal 
Product Code (UPC),13 which is a barcode primarily used for scanning items at the point of sale. 
The UPC is used to identify products to a very granular levelsuch as where in stores the 
product is displayed, and whether the product has temporary promotional packagingand the 
UPC for the same version or model of a device can change frequently. 
With respect to class I devices that are consumer health products, FDA believes that the entry of 
UDI data into GUDID, especially given the frequent changes to the UPCs serving as the UDIs 
for these devices, is burdensome to stakeholders. Further, FDA considered the public health 
benefit of GUDID submission for consumer health products and the risks to public health if 
GUDID submission is not provided for these devices. After reviewing available postmarket 
information, such as medical device reports and recall data for class I devices, FDA has a better 
understanding of the devices and device characteristics for which GUDID information is 
particularly useful in evaluating and improving device safety throughout a product lifecycle, as 
well as those for which GUDID information may be less important in this regard. Based on this 
analysis, at this time, FDA does not intend to enforce the GUDID submission requirements under 
21 CFR 830.300 for consumer health products. 
requirements (21 CFR 801.18, 21 CFR 801.20, 21 CFR 801.50, and 21 CFR 830.300) prior to September 24, 2020, 
and direct mark requirements (21 CFR 801.45) prior to September 24, 2022.   
11 83 FR 55372 (Nov. 5, 2018). This previous version of the guidance retained the original compliance policy and 
clarified FDAs policy on direct marking requirements for certain non-sterile devices in inventory.
12 85 FR 39477 (Jul. 1, 2020). This previous version of the guidance stated that FDA did not intend to enforce 
standard date formatting, UDI labeling, and GUDID data submission requirements under 21 CFR 801.18, 21 CFR 
801.20, 21 CFR 801.50, and 21 CFR 830.300 for class I and unclassified devices, other than I/LS/LS devices, before 
September 24, 2022.  
13 For class I devices, the UDI Rule provides that the UPC may serve as the UDI (21 CFR 801.40(d)). As with the 
production identifier exception for class I devices (21 CFR 801.30(d)), this option for a UPC was provided after 
weighing the public health benefit against the burden on industry with respect to these lower risk devices.
4 Contains Nonbinding Recommendations
Class I devices that FDA does not consider to be consumer health products may pose greater 
risks to public health. These devices are typically used in healthcare settings and are often 
subject to additional regulatory controls, such as the requirement to submit premarket 
notification, restrictions under section 520(e) of the FD&C Act, and other requirements. For 
these devices, FDA has determined that submission of UDI data into GUDID is particularly 
important to help enable FDA and other stakeholders to evaluate and improve device safety 
throughout the product lifecycle.14 Submission of UDI data into GUDID for these devices may 
also help reduce medical errors and simplify the integration of device use information into data 
systems.15 These devices are discussed further in section III.B.2.  
Section III.B.2 and section III.C also explain that we intend to extend our existing compliance 
policy regarding GUDID submission requirements for class I and unclassified devices, other than 
I/LS/LS devices, regardless of whether they are consumer health products, for an additional 75 
calendar days. In the 2020 UDI Compliance Policy Guidance, FDA stated that we did not intend 
to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and 
unclassified devices, other than I/LS/LS devices, before September 24, 2022.16 We recognize, 
however, that the new policy regarding consumer health products, described in section III.B of 
this guidance, is being finalized close to that date and that some labelers may have been waiting 
for the publication of this guidance before planning for GUDID submission. In light of these 
considerations, at this time, we do not intend to enforce the GUDID submission requirements 
under 21 CFR 830.300 for class I and unclassified devices, other than I/LS/LS devices, before 
December 8, 2022. We believe this brief extension of the policy may help facilitate submission 
of high quality UDI data to GUDID and is consistent with the public health. The other policies 
and related dates in this guidance remain the same and have not changed since the publication of 
the 2020 UDI Compliance Policy Guidance. FDAs UDI webpage17 contains additional 
information about UDI compliance dates and other dates related to UDI compliance policies.
Additionally, as explained in prior versions of this guidance, meeting the UDI direct mark 
requirements for certain finished devices that are manufactured and labeled before the labeler 
has implemented direct marking and that remain in inventory has been challenging for 
labelers. The cost of remediating existing devices in inventory to add a direct mark may be 
substantial, as it can entail different design changes and design validations than those made in 
order to add a required UDI direct mark to future lots of the device.
The compliance policy described in section IV of this guidance for certain devices in inventory 
that do not comply with the direct mark requirements is intended to facilitate use of those devices 
while still realizing some UDI-related benefits to patient safety. The lower burden of the 
approach outlined in this guidance also helps reduce the risk that industry will choose to avoid 
the cost of remediation by discarding inventory, potentially creating device shortages and 
14 GUDID data may be used to facilitate recalls and medical device reporting, in analysis of premarket approval 
application (PMA) annual reports, and for other FDA processes.
15 The preamble to the UDI Rule discusses the potential benefits of GUDID submission in more detail (see 78 FR 
58786).
16 See 85 FR 39477 (Jul. 1, 2020).
17 Available at: https://www.fda.gov/udi 
5 Contains Nonbinding Recommendations
negatively impacting patients and providers. At this time, we have concluded that this direct 
mark compliance policy for certain inventory devices appropriately serves the public health.
III.  Policy On Standard Date Formatting, UDI Labeling, 
and GUDID Submission Requirements for Class I and 
Unclassified Devices
Compliance Policy for Standard Date Formatting and 
UDI Labeling Requirements for Class I and Unclassified 
Devices
As previously stated in the 2020 UDI Compliance Policy Guidance, FDA does not intend to 
enforce standard date formatting and UDI labeling requirements under 21 CFR 801.18, 21 CFR 
801.20, and 21 CFR 801.50 for class I and unclassified devices, other than I/LS/LS devices,18
before September 24, 2022.19
We note that, pursuant to 21 CFR 801.30(a)(1), a finished device manufactured and labeled prior 
to the compliance date established by FDA for 21 CFR 801.20 regarding that device is excepted 
from the requirement to bear a UDI for a period of three years after that compliance date. The 
compliance dates established in the preamble of the UDI Rule have not changed. Finished class I 
and unclassified devices, other than I/LS/LS devices, manufactured and labeled prior to 
September 24, 2018, are excepted from UDI labeling and GUDID submission requirements for a 
period of three years after the established compliance date or until September 24, 2021 (21 CFR 
801.30(a)(1)). However, FDA does not intend to enforce the requirements under 21 CFR 801.18, 
801.20, and 801.50 for class I and unclassified devices, other than I/LS/LS devices, prior to 
September 24, 2022, regardless of the date they are manufactured and labeled.
Compliance Policy for GUDID Submission Requirements 
for Class I Devices
1.  Class I Devices Considered Consumer Health Products
At this time, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 
830.300 for class I devices considered consumer health products that are required to bear a UDI 
on their labels and device packages. For purposes of this guidance, consumer health products 
means 510(k)-exempt class I devices that are sold directly to consumers over-the-counter in 
brick-and-mortar and/or online stores and that do not fall within one or more of the categories 
18 See footnote 2. 
19 This policy for standard date formatting and UDI labeling requirements under 21 CFR 801.18, 21 CFR 801.20, 
and 21 CFR 801.50 for class I and unclassified devices, other than I/LS/LS devices, remains the same as the policy 
in the 2020 UDI Compliance Policy Guidance. See 85 FR 39477 (Jul. 1, 2020). 
6 Contains Nonbinding Recommendations
identified in section III.B.2. In addition to being sold directly to consumers, some consumer 
health products may be sold to or used in professional healthcare facilities.20 Consumer health 
products are typically labeled with a UPC, which may serve as the UDI for class I devices (21 
CFR 801.40(d)).21
If a labeler has questions regarding whether their device is considered a consumer health product 
that is within the scope of this compliance policy, the labeler may contact the FDA at 
GUDIDSupport@fda.hhs.gov. 
2.  Class I Devices Not Considered Consumer Health Products 
by FDA
FDA has determined that class I devices that we do not consider consumer health products may 
pose greater risks to public health and, based on FDAs analysis, GUDID data is particularly 
important to monitoring the safety of these devices. These potentially higher risk devices are 
typically used exclusively in professional healthcare facilities and are often subject to additional 
regulatory controls. 
Class I devices that fall into one or more of the categories described below are not considered 
consumer health products for purposes of this guidance and, therefore, do not fall within the 
compliance policy described in section III.B.1 of this guidance. However, FDA does not intend 
to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices, other 
than I/LS/LS devices,22 regardless of whether they fall within that compliance policy, before 
December 8, 2022 (an additional 75 calendar days).23
a.  Class I Reserved Devices
The majority of class I devices are exempt from the 510(k) premarket notification process. 
However, any class I device that is intended for a use which is of substantial importance in 
preventing impairment of human health... or ... that presents a potential unreasonable risk of 
illness or injury is not exempt from the 510(k) notification process. FD&C Act section 
510(l)(1). These devices are typically referred to as Class I Reserved Devices. More 
20 Professional healthcare facility is defined as any environment where personnel with medical training are 
continually available to oversee or administer the use of medical devices. This includes, but is not limited to, 
hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, physicians offices, and 
outpatient treatment facilities; or a clinical laboratory. For more information, see the following guidance: Design 
Considerations for Devices Intended for Home Use, available at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/design-considerations-devices-intended-home-use.
21 Class I devices that bear UPCs on their labels and device packages are deemed to meet all UDI labeling 
requirements of 21 CFR 801, subpart B (21 CFR 801.40(d)), and the UPC will serve as the UDI required by 21 CFR 
801.20. These devices are not required to bear a UDI, in addition to a UPC, but may elect to do so.
22 See footnote 2.
23 In the 2020 UDI Compliance Policy Guidance, we stated that we do not intend to enforce the GUDID data 
submission requirements under 21 CFR 830.300 for class I devices, other than I/LS/LS devices, before September 
24, 2022. See 85 FR 39477 (Jul. 1, 2020).
7 Contains Nonbinding Recommendations
information about devices considered to be Class I Reserved Devices can be found on FDAs 
website.24
b.  Restricted Devices
Under section 520(e) of the FD&C Act, FDA may by regulation require that a device be 
restricted to sale, distribution, or use only upon written or oral authorization by a practitioner 
licensed by law to administer or use such device (i.e., prescription use) or such other conditions 
as may be prescribed in such regulation. For example, regulations restricting the sale, 
distribution, and use of in vitro diagnostic devices are located in 21 CFR part 809, subpart C.
c.  Implantable Devices
Implantable device is defined at 21 CFR 801.3 as a device that is intended to be placed in a 
surgically or naturally formed cavity of the human body and is regarded as an implantable 
device . . . only if it is intended to remain implanted continuously for a period of 30 days or 
more, unless the Commissioner of Food and Drugs determines otherwise in order to protect 
human health. 
d.  Life-Supporting or Life-Sustaining Devices
Life-supporting or life-sustaining device is defined at 21 CFR 860.3 as a device that is 
essential to, or that yields information that is essential to, the restoration or continuation of a 
bodily function important to the continuation of human life. FDA recommends evaluating the 
characteristics of the device and looking to the devices intended use to determine whether a 
particular device is life-supporting or life-sustaining. 
e.  Certain Devices Distributed to Professional Healthcare Facilities and 
Intended for Use by Healthcare Professionals Only
The compliance policy described in section III.B.1 does not apply to devices that are distributed 
to professional healthcare facilities,  are intended for use by healthcare professionals only, and 
are: (1) reusable or reprocessed,25 including those that are non-sterile and sterilized on-site before 
use; or (2) intended for wound care. 
Compliance Policy for GUDID Submission Requirements 
for Unclassified Devices
24 Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/3151.cfm 
25 For purposes of this guidance, consistent with FDAs Direct Mark Guidance, available at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-direct-
marking-devices, we consider a device to be reusable if it is intended to be used more than once, meaning that it is 
intended for repeated uses on or by different patients. If the device is intended to be used more than once on or by 
the same patient, and not on or by multiple patients, it is not considered reusable for purposes of this guidance. Also 
consistent with the Direct Mark Guidance, we consider a device intended to be reprocessed if it is intended to 
undergo high-level disinfection and/or sterilization before each use or between uses.
8 Contains Nonbinding Recommendations
An unclassified device is a pre-amendments device type26 for which a classification regulation 
has not been promulgated. Unclassified devices generally require submission of a 510(k) 
premarket notification. FDA has issued compliance policies related to certain unclassified 
devices.27 FDA does not intend to enforce the GUDID submission requirements under 21 CFR 
830.300 for unclassified devices, other than I/LS/LS devices,28 before December 8, 2022 (an 
additional 75 calendar days).29
IV.  Policy for Direct Mark of Certain Devices
A.  Class III, LS/LS, and Class II NonSterile Devices 
Manufactured and Labeled Prior to the Established Direct 
Mark Compliance Date That Remain in Inventory
The policy in this section IV.A. of this guidance applies only to finished class III, LS/LS, and 
class II devices that are non-sterile, that were manufactured and labeled prior to their established 
direct mark compliance date, and that remain in inventory.30In general, the direct mark 
compliance date for class III devices is September 24, 2016; for LS/LS devices is September 24, 
2015; and for class II devices is September 24, 2018.31However, pursuant to 21 CFR 
801.30(a)(1), finished devices manufactured and labeled prior to the applicable compliance date 
established by FDA for 21 CFR 801.20 are not required to comply with UDI requirements, 
including direct mark requirements under 21 CFR 801.45, until three years after that labeling 
compliance date.32This provision was intended to reduce burden associated with the UDI Rule 
for inventories of finished devices that were manufactured and labeled prior to the applicable 
compliance date.33
For the class III, LS/LS, and class II devices described above, including device constituents of a 
copackaged combination product or kit, FDA does not intend to enforce UDI direct mark 
requirements under 21 CFR 801.45 when the devices UDI can be derived from other 
information directly marked on the device.
26 A pre-amendments device type is one that was in commercial distribution before May 28, 1976, the date the 
Medical Device Amendments were signed into law.
27 See the following guidance: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification 
Requirements, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/intent-
exempt-certain-unclassified-medical-devices-premarket-notification-requirements  
28 See footnote 2.
29 In the 2020 UDI Compliance Policy Guidance, we stated that we do not intend to enforce the GUDID data 
submission requirements under 21 CFR 830.300 for unclassified devices, other than I/LS/LS devices, before 
September 24, 2022. See 85 FR 39477 (Jul. 1, 2020).
30 For other categories of devices subject to direct marking under 21 CFR 801.45, please see our website at: 
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-alternatives-
and-time-extensions for additional information that may be applicable.
31 See 78 FR at 58815-58816.
32 This exception has expired for all devices.
33 See 78 FR at 58798.
9 Contains Nonbinding Recommendations
In determining whether a devices UDI can be derived from other information directly 
marked on the device, FDA intends to consider whether the labeler has developed and made 
available a method for constructing the UDI from other information directly marked on the 
device (such as catalog number, lot number, serial number) such that the UDI is readily 
available at the point of use and has documented or referenced that method in the DMR. 
FDA also intends to develop a new field(s) in GUDID to capture that a device is subject to 
such a method for constructing the UDI. We recommend that labelers use the new field(s) to 
document, when applicable, that their devices are subject to such a method when the field 
becomes available.
B.  Class I and Unclassified Devices
The direct mark compliance date for class I and unclassified devices, except for LS/LS devices,34
is September 24, 2020.35 As previously stated in the 2020 UDI Compliance Policy Guidance, 
FDA does not intend to enforce UDI direct mark requirements under 21 CFR 801.45 for those 
devices before September 24, 2022.36 This policy applies to sterile and non-sterile devices and 
includes device constituents of a copackaged combination product or kit.
In addition, after September 24, 2022, FDA does not intend to enforce UDI direct mark 
requirements under 21 CFR 801.45 for finished class I and unclassified devices, including class I 
and unclassified device constituents of a copackaged combination product or kit, that are not 
LS/LS, that are non-sterile, that were manufactured and labeled prior to September 24, 2022, and 
that remain in inventory, when the devices UDI can be derived from other information directly 
marked on the device. In determining whether a devices UDI can be derived from other 
information directly marked on the device, FDA intends to consider whether the labeler has 
developed and made available a method for constructing the UDI from other information directly 
marked on the device (such as catalog number, lot number, serial number) such that the UDI is 
readily available at the point of use and has documented or referenced that method in the DMR. 
As noted above, FDA intends to develop a new field(s) in GUDID to capture that a device is 
subject to such a method for constructing the UDI. We recommend that labelers use the new 
field(s) to document, when applicable, that their devices are subject to such a method when the 
field becomes available.
34 See footnote 2. 
35 See 78 FR at 58815-58816.
36 This policy for UDI direct mark requirements under 21 CFR 801.45 for class I and unclassified devices, other than 
LS/LS devices, remains the same as the policy in the 2020 UDI Compliance Policy Guidance. See 85 FR 39477 (Jul. 
1, 2020).
10