[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(GUDID): Draft Guidance for Industry'' in order to finalize the 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 Draft guidance 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