[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Unique Device Identification: Convenience Kits; Draft Guidance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availability of the draft guidance entitled ``Unique Device
Identification: Convenience Kits; Draft Guidance for Industry and Food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 This draft
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 4, 2016.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: [email protected].
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 [email protected] 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