[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Notices]
[Pages 94-95]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4048]


Unique Device Identification: Convenience Kits; Draft Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Unique Device 
Identification: Convenience Kits; Draft Guidance for Industry and Food 
and Drug Administration Staff.'' This proposed guidance document is 
intended to outline the Agency's current thinking that for purposes of 
Unique Device Identification (UDI) labeling and data submission 
requirements, the term ``convenience kit'' applies solely to two or 
more different medical devices packaged together for the convenience of 
the user, where they are intended to remain packaged together and not 
replaced, substituted, repackaged, sterilized, or otherwise processed 
or modified before the devices are used by an end user. This draft 
guidance is not final nor is it in effect at this time. When finalized, 
this guidance document will constitute a change in policy.

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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 4, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-4048 for ``Unique Device Identification: Convenience Kits; 
Draft Guidance for Industry and Food and Drug Administration Staff.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states

[[Page 95]]

``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 draft guidance document entitled 
``Unique Device Identification: Convenience Kits; Draft 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.

FOR FURTHER INFORMATION CONTACT: 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: gudidsupport@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 226 of the Food and Drug Administration Amendments Act of 
2007 and section 614 of the Food and Drug Administration Safety and 
Innovation Act amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) to add and amend section 519(f) (21 U.S.C. 360i(f)), which 
directs FDA to publish regulations establishing a unique device 
identification system for medical devices. The UDI system final rule 
was published on September 24, 2013 (78 FR 58786) (the UDI Rule).
    The overarching objective of the UDI Rule, as required by section 
519(f) of the FD&C Act, is to provide a system to adequately identify 
medical devices through distribution and use. We interpret this to mean 
that the form of a UDI should, in conformity with 21 CFR 801.40, be 
available to identify a device in both easily readable plain-text and 
in a form that can be entered into an electronic patient record or 
other computer system via an automated process when the device is used 
by an end user.
    The term ``convenience kit'' is defined at 21 CFR 801.3 as ``two or 
more different medical devices packaged together for the convenience of 
the user.'' Under 21 CFR 801.30(a)(11), individual devices packaged 
within a convenience kit are excepted from the UDI labeling 
requirements, provided the UDI is on the label of the immediate 
container of the convenience kit. The preamble to the UDI Rule 
expressed our thinking at the time that medical procedure kits, 
including orthopedic procedure kits, are convenience kits.
    Since the publication of the UDI Rule, we have determined that 
interpreting the term ``convenience kit'' at Sec.  801.3 to include 
implantable devices and instruments that are provided by the labeler in 
sets or trays as non-sterile and repeatedly reconfigured and sterilized 
(or cleaned and sterilized) prior to use would be inconsistent with the 
purpose of the exceptions at Sec.  801.30 and the UDI Rule generally. 
In this draft guidance, FDA proposes to interpret the term 
``convenience kit'' at Sec.  801.3 as applying solely to two or more 
different medical devices packaged together for the convenience of the 
user where they are intended to remain packaged together and not 
replaced, substituted, repackaged, sterilized, or otherwise processed 
or modified before the devices are used by an end user.

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 Unique Device 
Identification for Convenience Kits. It does not establish any rights 
for any person is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health 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 http://www.regulations.gov. Persons unable to download 
an electronic copy of ``Unique Device Identification: Convenience Kits; 
Draft Guidance for Industry and Food and Drug Administration Staff'' 
may send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. Please use the document number 1500010 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    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 part 801, subpart B have been approved 
under OMB control number 0910-0720.

    Dated: December 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33008 Filed 12-31-15; 8:45 am]
 BILLING CODE 4164-01-P