[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58545-58546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23058]
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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Global Unique Device Identification Database; Draft Guidance for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availability of the draft guidance entitled ``Global Unique Device
Identification Database (GUDID).'' FDA is issuing this draft guidance
to communicate our current thinking of how the GUDID will operate. The
guidance includes both information about how device labelers (in most
instances, the device manufacturer) will interface with the GUDID, as
well as information on the database elements that must be submitted to
the GUDID and their definitions. We intend to publish a final guidance
after the close of the comment period and our implementation of the
GUDID.
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 on 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 25, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Global Unique Device Identification
Database (GUDID)'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send
a fax request to 301-847-8149 to receive a hard copy. Alternatively,
you may submit written requests for single copies of the draft guidance
to the Office of Communication, Outreach and Development (HFM-40),
Center for Evaluation and Research, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Jay Crowley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3216, Silver Spring, MD 20993-0002, email:
[email protected]; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
Section 226 of the Food and Drug Administration Amendments Act of
2007, 121 Stat. 854, and Section 614 of the Food and Drug
Administration Safety and Innovation Act (FDASIA) of 2012, 126 Stat.
1061, 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 system for medical devices
along with implementation timeframes for certain medical devices. The
unique device identification (UDI) system proposed rule was published
on July 10, 2012 (77 FR 40736), followed by an amendment modifying the
implementation timeframe for certain devices, which was published on
November 19, 2012 (77 FR 69393).
In developing the proposed rule, FDA solicited and considered input
from a variety of stakeholders (e.g., manufacturers, global regulatory
bodies, the clinical community, patient advocates) to ensure that as
many perspectives as possible were incorporated. The GUDID is a
critical component of the UDI System. While the UDI assigned to each
device is a globally unique, yet unintelligent code, the GUDID will
house a uniform set of required attribute information, including the
device identifier (DI) component of the UDI, for the devices reported
to the GUDID. Being unique for each device, the DI component of the UDI
can be effectively used by stakeholders to access the other GUDID
attribute information for that device.
Labelers will be responsible for submitting information to the
GUDID as part of their UDI requirements. This draft guidance document
describes how labelers would obtain access to the GUDID, how to submit
DI records to the GUDID, and how all stakeholders can search and
retrieve device information. This draft guidance is being issued to
provide general information about the GUDID.
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 Agency's current thinking on 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 may be
used if such approach satisfies the requirements of the applicable
statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using 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. To receive ``Global
Unique Device Identification Database (GUDID),'' you may either send an
email request to [email protected] to receive an electronic copy of
the document or send
[[Page 58546]]
a fax request to 301-847-8149 to receive a hard copy. Please use the
document number 1831 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to proposed collections of information
described in FDA's July 10, 2012, proposed rule on the UDI system (77
FR 40736), which this draft guidance is intended to interpret. The
proposed collections of information in the proposed rule are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). As required by
the PRA, FDA has published an analysis of the information collection
provisions of the proposed rule (77 FR 40736 at 40762) and has
submitted them for OMB approval (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: September 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23058 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P