[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33568-33569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0636]
Global Unique Device Identification Database; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Global Unique Device
Identification Database (GUDID): Guidance for Industry''. FDA has
updated sections of the document, ``Global Unique Device Identification
(GUDID): Draft Guidance for Industry'' in order to finalize the
sections with the most questions from GUDID submitters. The guidance
includes information about how device labelers (in most instances, the
device manufacturer) will interface with the GUDID by establishing
GUDID accounts and beginning their initial submissions. Draft guidance
sections on the device identifier (DI) module have not been finalized
in this document and will be addressed in a future document.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: 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 guidance document entitled
``Global Unique Device Identification Database (GUDID): Guidance for
Industry'' 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 single copies of the guidance to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Bldg. 71, Rm. 3128, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to the office that you are ordering from to assist in processing
your request.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: For information concerning the
guidance as it relates to devices regulated by CDRH: Indira R. Konduri,
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:
[email protected].
For information concerning the guidance as it relates to devices
regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 226 of the Food and Drug Administration Amendments Act of
2007 (Public Law 110-85, 121 Stat. 824) and section 614 of the Food and
Drug Administration Safety and Innovation Act (Pub. L. 112-144, July 9,
2012) amended the Federal Food, Drug, and Cosmetic Act to add section
519(f) (21 U.S.C. 360i(f)), which directs FDA to issue regulations
establishing a unique device identification (UDI) system for medical
devices along with implementation timeframes for certain medical
devices. The UDI system final rule was published on September 24, 2013
(78 FR 58785).
In developing the final rule, FDA solicited and considered input
from a variety of stakeholders (e.g., manufacturers, global regulatory
bodies, the clinical community, and patient advocates) to ensure that
as many perspectives as possible were incorporated. The GUDID is a
critical component of the UDI system. The UDI assigned to each device
is a globally unique, yet unintelligent code identifying the device,
and is composed of the static DI portion and the dynamic production
identifier. The GUDID will house the DI, along with key descriptive or
``attribute'' information about the device, which is reported and
updated to the GUDID by the device labeler. Being unique for each
device, the DI component of the UDI can be effectively used by
stakeholders to access the GUDID attribute information for that device.
Labelers are responsible for submitting information to the GUDID.
This guidance provides general information to labelers that will enable
them to obtain a GUDID account and begin initial submissions to the
GUDID. A draft version of this document (the ``draft guidance'') was
released on September 24, 2013 (78 FR 58545), with a 60-day comment
period, which ended on November 25, 2013. More than 300 comments were
received from 21 entities. To provide labelers with the most accurate
information as soon as it is available, we are finalizing this document
in two phases. The first part of the finalized guidance, which is now
being made available, addresses sections of the draft guidance that
received the most comments and questions. The remaining sections of the
draft guidance, including sections on the DI module, will be finalized
in one or more parts to be published at a later date.
Keyed to the sections of the draft guidance, the guidance document
released today deals with the following topics and the related comments
and questions received during the comment period ended on November 25,
2013: (The remaining sections will be finalized at a later time.)
2--Unique Device Identifier
3--Global Unique Device Identification Database
3.1. GUDID Key Concepts
3.1.1 GUDID Account
3.1.2.2 Global Medical Device Nomenclature
3.2 GUDID Modules
3.2.1 GUDID Web Interface
3.2.1.1 GUDID Account Management Module
[[Page 33569]]
4--GUDID Submission and 21 CFR 11 Requirements
Appendix D--GUDID Attributes Mapped to a Fictitious Medical Device
Label
Glossary
We are making available on the Internet at the FDA/UDI Web site
(http://www.fda.gov/udi) updated versions of two appendices of the
draft guidance: The section formerly identified as ``Appendix B'',
which summarizes the device attribute information that will populate
the GUDID, renamed as ``GUDID Data Elements Reference Table''; and the
section formerly identified as ``Appendix C'', which summarizes the UDI
formats accepted by the issuing agencies that FDA has accredited to
date, renamed as ``UDI Formats by FDA-Accredited Issuing Agency''.
These two documents contain technical specifications only, and we
therefore are not going to publish them as a part of guidance that
describes the Agency's interpretation of or policy on a regulatory
issue. For those without Internet access or who otherwise would like to
receive a hard copy of the currently updated version of either of these
documents, formerly published as Appendix B and Appendix C of the draft
guidance, please call the Contact Person (see FOR FURTHER INFORMATION
CONTACT) to request the document(s).
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking about the GUDID. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach for interfacing with the GUIDID may be
used with prior FDA approval if such approach satisfies the technical
requirements of the GUDID and the requirements of the applicable
statute and regulations. If you wish to use an alternative approach for
submitting a specific required data element, you may request FDA
approval by email or writing to: UDI Regulatory Policy Support, Center
for Devices and Radiological Health, Food and Drug Administration,
Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, email: [email protected] (Attention: UDI Regulatory Policy
Support). If a labeler has a waiver from electronic submission of GUDID
data under Sec. 830.320(c) (21 CFR 830.320(c)), the labeler must send
a letter containing all of the information otherwise required by this
guidance, as well as any permitted ancillary information that the
labeler wishes to submit, within the time permitted to: UDI Regulatory
Policy Support at the address indicated in the previous sentence. (See
Sec. 830.320(c)(3).)
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or at http://www.regulations.gov. Persons unable to download an electronic copy of
``Global Unique Device Identification Database (GUDID): Guidance for
Industry'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 1831 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This 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 collection of information in 21 CFR part 830 pertaining to
GUDID labeler accounts and data submissions addressed in this guidance
document has been approved under OMB control number 0910-0720.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13568 Filed 6-10-14; 8:45 am]
BILLING CODE 4164-01-P