[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48814-48816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1853]


Unique Device Identification System: Form and Content of the 
Unique Device Identifier; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance for industry and FDA staff entitled 
``Unique Device Identification System: Form and Content of the Unique 
Device Identifier (UDI).'' When finalized, this draft document will 
define the expected content and forms of the unique device identifier 
(UDI), to assist both labelers and FDA-accredited issuing agencies 
better ensure the UDIs developed under systems for the issuance of UDIs 
are in compliance with the unique device identification system rule 
(UDI Rule). This draft guidance is not the final version of the 
guidance nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1853 for ``Unique Device Identification System: Form and 
Content of the Unique Device Identifier (UDI).'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the

[[Page 48815]]

information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Unique Device Identification System: Form and Content of the Unique 
Device Identifier (UDI)'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 66, rm. 5431, Silver Spring, MD 20993-0002. Alternatively, you 
may submit written requests for a single copy of the draft guidance to 
the Office of Communications, Outreach, and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: UDI Regulatory Policy Support, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, rm. 3303, Silver Spring, MD 20993-
0002, 301-796-5995, [email protected]. 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.

SUPPLEMENTARY INFORMATION:

I. Background

    The UDI Rule, establishing the unique device identification system, 
was published on September 24, 2013 (78 FR 58786). The main objective 
of the UDI system is to adequately identify devices through 
distribution and use. Among other requirements, the UDI Rule requires 
the label and device packages of every medical device distributed in 
the United States to bear a UDI, unless an exception or alternative 
applies (21 CFR 801.20).
    The UDI Rule is intended to create a standardized identification 
system for medical devices used in the United States that makes it 
possible to rapidly and definitively identify a device and some key 
attributes that affect its safe and effective use. The UDI Rule 
specifies that the labeler, as defined under Sec.  801.3 (21 CFR 
801.3), is responsible for complying with the UDI labeling (21 CFR part 
801, subpart B) and Global Unique Device Identification Database 
(GUDID) submission (21 CFR part 830, subpart E) requirements. The UDI 
Rule also requires UDIs to be issued under a system operated by an FDA-
accredited issuing agency (21 CFR 830.20(a)). Each labeler, therefore, 
must work with one or more FDA-accredited issuing agencies to develop 
UDIs for devices that are required to bear a UDI. In order for there to 
be an effective identification system, it is essential that the FDA-
accredited issuing agencies develop and operate systems for the 
assignment of UDIs that allow labelers using these systems to be in 
compliance with UDI labeling requirements.
    In this guidance, when finalized, we describe the two forms of a 
UDI and clarify the content of the UDI, including the data delimiters 
that identify specific data elements within the UDI. The order of the 
data in a UDI and UDI carrier are discussed as well.
    The UDI, as defined under Sec.  801.3, is an identifier that 
adequately identifies a device through its distribution and use. A UDI 
is composed of: (1) A device identifier (DI), (2) typically one or more 
production identifiers (PIs) when included in a device label, and (3) 
the data delimiters for the DI and PIs included in the UDI. The 
regulation at Sec.  801.40(a) (21 CFR 801.40(a)) specifies that the UDI 
must be presented in both easily readable plain-text and automatic 
identification and data capture (AIDC) technology forms on the label of 
the device and on each device package. For those devices required to be 
directly marked with a UDI under 21 CFR 801.45, the UDI may be provided 
through either or both forms, or any alternative technology that will 
provide the UDI of the device on demand. ``Easily readable plain-text'' 
means the legible interpretation of the data characters encoded in the 
AIDC form of the full UDI, including the data delimiters. The easily 
readable plain-text form of the UDI should include the DI, any PIs, and 
data delimiters contained in the UDI. The UDI Rule does not require the 
use of specific forms of AIDC or specific AIDC technologies to present 
the UDI, and labelers may choose to use more than one type of AIDC 
technology form. The AIDC form of the UDI must be in a format that can 
be read by a bar code scanner or some other AIDC technology. If a 
labeler choses a bar code form of AIDC, we expect that the bar code 
form of the UDI will be tested for print quality.
    We interpret Sec. Sec.  801.3 and 801.40 as specifying that a UDI 
is composed solely of a single DI and one or more of the five PIs 
listed in Sec. Sec.  801.3 and 801.40(b), along with the data 
delimiters for the DI and PIs. While some of the FDA-accredited issuing 
agencies may allow for non-UDI elements, such as quantity, in the UDI 
carrier, we do not recognize any such additional non-UDI elements as 
being part of the UDI. For the purposes of this draft guidance, ``data 
delimiter'' means a defined character or set of characters that 
identifies specific data elements within an encoded data string. The 
data delimiters indicate the DI value or the PI values that follow each 
data delimiter within the UDI, and may also indicate other non-UDI 
elements that may be included within the UDI carrier. Data delimiters 
for the DI and PIs should be included in the UDI. If non-UDI elements 
are included in the UDI carrier, separate data delimiters for any these 
non-UDI elements outside the scope of a UDI should be included in the 
UDI carrier. Data delimiters should be included in both the easily 
readable plain-text and AIDC technology forms of the UDI. The data 
delimiters vary based on the FDA-

[[Page 48816]]

accredited issuing agencies, and consist of a specific set of 
characters used to identify the information immediately following the 
data delimiter.
    For purposes of this draft guidance, we define ``UDI carrier'' as 
the means to convey the UDI and any non-UDI elements by using easily 
readable plain-text and AIDC forms. In the UDI carrier, the data 
represented in the UDI should precede any non-UDI elements and should 
be distinguishable from the UDI elements. The easily readable plain-
text form of the UDI should be ordered to specify the DI first, 
followed by the PIs. If there are any non-UDI elements in the UDI 
carrier, the non-UDI elements should follow the PIs that are part of 
the UDI. For more information on non-UDI elements capable of being 
included in the UDI carrier, labelers should contact their FDA-
accredited issuing agency.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Unique 
Device Identification System: Form and Content of the Unique Device 
Identifier (UDI)''. 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.

III. Request for Comments

    FDA is seeking additional information on this issue. FDA is 
particularly interested in receiving information relating to the 
following question: Are there any additional standards, in addition to 
those referenced in this draft guidance, that should be used to 
determine the print quality of the AIDC form of the UDI?

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents 
are also available at http://www.regulations.gov. Persons unable to 
download an electronic copy of ``Unique Device Identification System: 
Form and Content of the Unique Device Identifier (UDI)'' may send an 
email request to [email protected] or [email protected], or by 
calling 1-800-835-4709 or 240-402-7800, to receive an electronic copy 
of the document. Please use the document number GUD1500035 to identify 
the guidance you are requesting.

V. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information described in FDA regulations. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 801 have been 
approved under OMB control number 0910-0485, and the collections of 
information in 21 CFR part 830 have been approved under OMB control 
number 0910-0720.

    Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17554 Filed 7-25-16; 8:45 am]
 BILLING CODE 4164-01-P