Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments, 48814-48816 [2016-17554]
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48814
Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Numbers of
respondents
Numbers of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Submission of rotational plans for health
warning statements ..............................
100
1
100
60
6,000
1 There
$1,200
are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 100
respondents will respond to this
collection of information and take 60
hours to complete a rotational warning
plan for a total of 6,000 burden hours.
In addition, capital costs are based on
100 respondents mailing in their
submission at a postage rate of $12 for
a 5-pound parcel (business parcel post
mail delivered from the furthest
delivery zone). Therefore, FDA
estimates that the total postage cost for
mailing the rotational warning plans to
FDA to be $1,200.
In the Federal Register of February,
19, 2016 (81 FR 8505), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. One comment was PRA
related comment was received.
(Comment) The comment believes
that warning plans should not be
renewed every year, but should remain
in force as long as necessary after their
approval
(Response) FDA does not require that
a previously FDA-approved warning
plan be resubmitted. FDA reviews and
approves warning plans only once,
unless a submitter seeks to change the
distribution or display of warnings on
packages or rotation of warnings in
advertisements, in which case the
submission would be considered a
supplement. The purpose of FDA’s
proposed extension is to account for the
entry of new smokeless tobacco product
brands and advertising onto the market
place.
Dated: July 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17569 Filed 7–25–16; 8:45 am]
BILLING CODE 4164–01–P
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Device Identifier; Draft Guidance for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.
Notice of availability; request
for comments.
ACTION:
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:
SUMMARY:
Electronic Submissions
srobinson on DSK5SPTVN1PROD with NOTICES
Total capital
costs
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
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20:28 Jul 25, 2016
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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 https://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
https://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
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srobinson on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
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 https://
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: https://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 https://
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
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20:28 Jul 25, 2016
Jkt 238001
assist that office in processing your
request.
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, 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.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
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 § 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 FDAaccredited 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 § 801.3, is
an identifier that adequately identifies a
device through its distribution and use.
A UDI is composed of: (1) A device
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48815
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
§ 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 plaintext 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 §§ 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 §§ 801.3 and 801.40(b),
along with the data delimiters for the DI
and PIs. While some of the FDAaccredited 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-
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Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
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 plaintext 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.
srobinson on DSK5SPTVN1PROD with NOTICES
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm or at
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm. Guidance
documents are also available at https://
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
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20:28 Jul 25, 2016
Jkt 238001
request to CDRH-Guidance@fda.hhs.gov
or ocod@fda.hhs.gov, 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
invites comments on the information
collection provisions of our regulations
requiring reporting and recordkeeping
for processors and importers of fish and
fishery products.
DATES: Submit either electronic or
written comments on the collection of
information by September 26, 2016.
SUMMARY:
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ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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–
2013–N–0879 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
E:\FR\FM\26JYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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, 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.
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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents
are also available at https://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 CDRH-Guidance@fda.hhs.gov or ocod@fda.hhs.gov, 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
