[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36530-36532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15020]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0636]
Global Unique Device Identification Database; Guidance for
Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled
[[Page 36531]]
``Global Unique Device Identification Database (GUDID): Guidance for
Industry and Food and Drug Administration Staff.'' This guidance
finalizes, as a single document, all sections of, ``Global Unique
Device Identification (GUDID): Draft Guidance for Industry.'' The
guidance includes, with minor modifications, the previously finalized
sections on how device labelers will interface with the GUDID,
establish GUDID accounts and begin initial submissions. The guidance
also finalizes the sections on the Device Identifier (DI) record,
Health Level 7 Structured Product Labeling (HL7 SPL) submission,
search/retrieval of devices information, and GUDID submissions and
maintaining and submitting electronic records. The guidance also
finalizes Appendix A--GUDID Package Information Examples.
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 and Food and Drug Administration Staff'' 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 or 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 from which you are ordering 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 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 (Pub. L. 110-85) and section 614 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144) 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 58786).
In developing the final rule, FDA solicited and considered input
from a variety of stakeholders including 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.
On September 24, 2013 (78 FR 58545), FDA released a document titled
``Global Unique Device Identification (GUDID): Draft Guidance for
Industry'' (the draft guidance). During the 60-day comment period,
which ended on November 25, 2013, more than 300 comments were received
from 21 entities. In order to finalize the sections with the most
questions from GUDID submitters, FDA released the first part of this
finalized guidance on June 11, 2014 (79 FR 33568), providing general
information to labelers to enable them to obtain a GUDID account and
begin initial submissions to the GUDID.
FDA is now, in a single document, finalizing all sections of the
draft guidance. The finalized guidance includes, with minor
modifications, the previously released information on how device
labelers will interface with the GUDID, establish GUDID accounts, and
begin initial submissions. The principal modifications include
reformatting changes to rearrange sections from 3.2. to 3.1 to improve
the document flow, adding a paragraph in section 2 in response to an
industry comment, and adding a paragraph in section 4 that had been
inadvertently omitted in the document released on June 11, 2014. In
addition, this guidance finalizes sections in the draft guidance on the
DI record, HL7 SPL submission, search/retrieval of devices information,
and GUDID submissions and 21 CFR part 11 requirements. We also are
finalizing Appendix A--GUDID Package Information Examples. This
guidance supersedes the June 11, 2014, guidance entitled ``Global
Unique Device Identification Database (GUDID): Guidance for Industry.''
Elsewhere, we continue to make 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
and will not be published as a part of this 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,
should call the people listed under 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
[[Page 36532]]
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 21 CFR 830.320(c), the
labeler should 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 21 CFR 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 have 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 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15020 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P