Document ID: FDA-2013-D-0636-0001
Agency: fda
Document Type: Notice
Title: Global Unique Device Identification Database; Draft Guidance for Industry; Availability
Posted Date: 2013-09-24T04:00Z

[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58545-58546]
From the Federal Register Online via the Government Printing 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Global Unique Device Identification Database; Draft Guidance for 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availability of the draft guidance entitled ``Global Unique Device 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 FDA is issuing this draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 25, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Global Unique Device Identification 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you may submit written requests for single copies of the draft guidance 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: 
udi@fda.hhs.gov; 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 dsmica@fda.hhs.gov 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