Contains Nonbinding Recommendations

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

Document issued on November 5, 2018.

This document supersedes Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Immediately In Effect Guidance for Industry and Food and Drug Administration Staff, issued January 16, 2018.

For questions about this document concerning CDRH-regulated devices contact UDI Regulatory Policy Support, 301-796-5995, email: GUDIDSupport@fda.hhs.gov.

For questions about this document concerning CBER-regulated devices contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.

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

Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 17029 to identify the guidance you are requesting.

CBER

Additional copies are available from the Center for Biologics Evaluation and Research (CBER), by written request, Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, by email, ocod@fda.hhs.gov or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInform ation/Guidances/default.htm

Contains Nonbinding Recommendations

Table of Contents

1. Introduction 1

2. Background 3

3. Policy On Standard Date Formatting, UDI Labeling, and GUDID Data Submission Requirements for Class I and Unclassified Devices 4

   1. Class I and Unclassified Devices Manufactured and Labeled on or After September 24, 2018 4

   2. Finished Class I and Unclassified Devices Manufactured and Labeled Before September 24, 2018

   ................................................................................................................................................................ 5

4. Policy for Direct Mark of Certain Devices 6

1. 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 6

2. Class I and Unclassified Devices 7

   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

   
   

   
   

   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.

   
   

   FDA’s unique device identification system is designed to adequately identify devices through distribution and use.1 The unique device identification system requirements are being 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) devices2 are:

   
   

   

   1 The final rule establishing the unique device identification system was published September 24, 2013 (78 FR 58786).

   2 Implantable, life-supporting, or life-sustaining devices of all classes 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. See 78 FR at 58815.

   
   

   
   

   

   

   September 24, 2018, for the following requirements: Standard date formatting (21 CFR 801.18),

   

   Labeling (21 CFR 801.20, 21 CFR 801.50), and

   

   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 FDA’s intention with regard to enforcement of these requirements for class I and unclassified devices.4 As described in further detail below, FDA does not intend to enforce standard date formatting, 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 these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under 21 CFR 801.45 for these devices before September 24, 2022.

   
   

   For other device classes, the compliance dates established for direct mark requirements (21 CFR 801.45) are:

   

   

   

   September 24, 2015, for LS/LS devices; September 24, 2016, for class III devices; and September 24, 2018, for class II devices.5

   
   

   This guidance also describes FDA’s 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 non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory. As described in further detail below, FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for these devices when the device’s unique device identifier (UDI) can be derived from other information directly marked on the device.

   
   

   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.

   
   

   This guidance 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)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health.

   
   

   

   3 See 78 FR at 58815-58816.

   4 The class I and unclassified devices compliance policy described in this guidance does 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 (see 21 CFR 801.30(a)(2)).

   5 See 78 FR at 58815-58816.

   
   

   Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate.

   
   

   FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and 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.

   
   

   II.

   On September 24, 2013, the FDA published a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use (the “UDI Rule”).6 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, 2020.7

   
   

   The UDI Rule requires a device to bear a UDI on its label and packages unless an exception or alternative applies (see 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 FDA’s GUDID (21 CFR 830.300). In addition, the final 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

   
   

   Fully realizing the benefits of the unique device identification system depends on UDI 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.

   
   

   
   

   

   6 78 FR 58786.

   7 See 78 FR at 58815-58816.

   8 See 78 FR at 58795.

   9 For more information on interpretation of 21 CFR 801.45, see “Unique Device Identification: Direct Marking of Devices Guidance for Industry and Food and Drug Administration Staff” published on November 17, 2017 at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM45 2262.pdf.

   
   

   As FDA and industry have worked to implement these requirements, the Agency has identified complex policy and technical issues that require resolution to help ensure that UDI data are high quality and are available in standardized ways. FDA received a large number of inquiries from labelers of class II, class III, and I/LS/LS devices relating to those policy and technical issues. Based on experience with UDI implementation to date, FDA anticipates receiving a similarly high volume of questions from labelers of class I and unclassified devices.

   
   

   To fully reap the public health benefits and a return on investment of the unique device identification system, the Agency intends to focus its resources on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices. Undertaking this endeavor now will help ensure the transition from development of the unique device identification system to widespread use and sustainability.

   
   

   Additionally, one remaining challenge for labelers is meeting the UDI direct mark requirements for devices finished and labeled before the labeler had achieved direct mark compliance but which remain in inventory on or after the applicable direct mark compliance date. 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.

   
   

   This guidance describes a compliance policy for certain devices in inventory that do not comply with the direct mark requirements under 21 CFR 801.45 when the device’s UDI can be derived from other information directly marked on the device. This policy allows some realization of the benefits of UDI to patient safety for inventory devices that do not bear a UDI. The lower burden of the approach outlined in this guidance also reduces the risk that industry will choose to avoid the cost of remediation by discarding inventory, potentially creating device shortages and negatively impacting patients and providers. Weighing the benefits and risks, we conclude that this compliance policy for certain inventory devices appropriately serves the public health.

   
   

   

   

   

   

   III.

   
   

   

   
   

   

   1. Class I and Unclassified Devices Manufactured and Labeled on or After September 24, 2018

      
      

      FDA does 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,10 before September 24, 2020.

      
      

   2. Finished Class I and Unclassified Devices Manufactured and Labeled Before September 24, 2018

Pursuant to 21 CFR 801.30(a)(1), a finished device manufactured and labeled prior to the compliance date established by the 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.

This provision is 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.11

While FDA does not intend to enforce the requirements under 21 CFR 801.18, 801.20, 801.50, and 830.300 for class I and unclassified devices, other than I/LS/LS devices, prior to September 24, 2020, the compliance dates established in the preamble of the UDI Rule have not changed. This means 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 data submission requirements for a period of three years after the established compliance date or until September 24, 2021 (see 21 CFR 801.30(a)(1)).

Although not covered by 21 CFR 801.30(a)(1), we also do not intend to enforce standard date format requirements under 21 CFR 801.18 during that same three-year period for finished class I and unclassified devices, other than I/LS/LS devices, manufactured and labeled before September 24, 2018.

Table 1.

10 Section 519(f) of the FD&C Act requires implementation of FDA’s unique device identification system regulations for I/LS/LS devices within two years of finalizing those regulations. For class I and unclassified I/LS/LS devices, the compliance date established by the FDA is September 24, 2015. See 78 FR at 58815- 58816.

11 See 78 FR at 58798.

Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018

September 24, 202112

IV.

1. 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

   
   

   The policy in this Section IV.A. of this guidance applies only to class III, LS/LS, and class II devices that are non-sterile, that are subject to direct mark requirements under 21 CFR 801.45, that were manufactured and labeled prior to their established direct mark compliance date, and that remain in inventory.13 In 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, 2018.14 However, pursuant to 21 CFR 801.30(a)(1), 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 date.15

   
   

   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 device’s UDI can be derived from other information directly marked on the device. For devices manufactured and labeled prior to their applicable compliance date established by FDA for 21 CFR 801.20, this policy applies after the expiration of the exception in 21 CFR 801.30(a)(1).

   
   

   In determining whether a device’s 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, documented or referenced that method in the Device Master

   
   

   

   12 As explained above, and 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.

   13 For other categories of devices subject to direct marking under 21 CFR 801.45, please see the table in Figure 2 on our website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIExceptio nsAlternativesandTimeExtensions/default.htm for additional information that may be applicable.

   14 See 78 FR at 58815-58816.

   15 21 CFR 801.30(a)(1) provides that a finished device manufactured and labeled prior to the applicable compliance date established by FDA for 21 CFR 801.20 is excepted from UDI requirements for a period of three years after that compliance date. As of the issuance of this guidance, this exception has expired for class III and LS/LS devices. For class II devices, the exception will expire on September 24, 2019.

   
   

   Record, and documented in GUDID that the devices are subject to that method. FDA intends to announce the availability of a new field(s) in GUDID to capture this information.

   
   

2. Class I and Unclassified Devices

The direct mark compliance date for class I and unclassified devices subject to direct mark requirements under 21 CFR 801.45, except for LS/LS devices,16 is September 24, 2020.17 FDA does not intend to enforce UDI direct mark requirements for those devices until September 24, 2022. 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 class I and unclassified devices, including class I and unclassified device constituents of a copackaged combination product or kit, that are non- sterile, that are subject to direct mark requirements under 21 CFR 801.45, that were manufactured and labeled prior to September 24, 2022, and that remain in inventory, when the device’s UDI can be derived from other information directly marked on the device. In determining whether a device’s 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, documented or referenced that method in the Device Master Record, and documented in GUDID that the devices are subject to that method. FDA intends to announce the availability of a new field(s) in GUDID to capture this information.

16 Section 519(f) of the FD&C Act requires implementation of FDA’s unique device identification system regulations for I/LS/LS devices within two years of finalizing those regulations. For class I and unclassified LS/LS devices, the direct mark compliance date established by the FDA is September 24, 2015. See 78 FR at 58815-58816.

17 See 78 FR at 58815-58816.