Document ID: FDA-2014-D-1182-0001
Agency: fda
Document Type: Notice
Title: Unique Device Identification System: Small Entity Compliance Guide;
Guidance for Industry; Availability
Posted Date: 2014-09-10T04:00Z

[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53712-53713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21480]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1182]

Unique Device Identification System: Small Entity Compliance 
Guide; 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 a guidance for industry entitled ``Unique Device 
Identification System: Small Entity Compliance Guide'' for a final rule 
published in the Federal Register of September 2013. This small entity 
compliance guide (SECG) intends to provide, in plain language, the 
requirements of the regulation and to help small businesses understand 
and comply with the regulation.

DATES: Submit either electronic or written comments on the SECG at any 
time.

ADDRESSES: Submit written requests for single copies of the SECG 
entitled ``Unique Device Identification System: Small Entity Compliance 
Guide'' 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), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist the office in processing your requests.
    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 CDRH questions regarding this 
document, contact UDI Regulatory Policy Support, 301-796-5995, email: 
udi@fda.hhs.gov. For CBER questions regarding this document, contact 
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

    FDA is announcing the availability of a document entitled: ``Unique 
Device Identification System: Small Entity Compliance Guide.''
    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 system for medical devices.
    In the Federal Register of September 24, 2013 (78 FR 58785), FDA 
published a final rule establishing a unique device identification 
system (the UDI Rule). Some parts of the rule became effective on 
October 24, 2013; the remaining parts became effective on December 23, 
2013. In addition, certain provisions within the rule have later 
compliance dates. In compliance with section 212 of the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), FDA is 
making available this SECG stating in plain language the legal 
requirements of the September 24, 2013, final rule.
    This level 2 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the Agency's current thinking on this topic. 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 statutes and 
regulations.

II. Paperwork Reduction Act

    This guidance refers to previously approved collections of 
information found 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 
collections of information in 21 CFR part 801 and 830 have been 
approved under OMB control number 0910-0720; the collections of 
information in part 803 have been approved under OMB control number 
0910-0437; the collections of information in part 806 have been 
approved under OMB control number 0910-0359; the collections of 
information in part 810 have been approved under OMB control number 
0910-0432; the collections of information in part 814 have been 
approved under 0910-0231; the collections of information in part 821 
have been approved under OMB control number 0910-0442; and the 
collections of information in part 822 have been approved under OMB 
control number 0910-0449.

III. 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

[[Page 53713]]

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.

IV. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at http://www.regulations.gov, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Persons unable to download an electronic 
copy of ``Unique Device Identification System: Small Entity Compliance 
Guide'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1400046 to identify the guidance you are requesting.

    Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21480 Filed 9-9-14; 8:45 am]
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