[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17835-17837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08472]
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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; 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 or Agency) is announcing
the availability of a final guidance entitled ``Unique Device
Identification: Convenience Kits; Guidance for Industry and Food and
Drug Administration Staff.'' The unique device identification system
regulations require that the label and device package of a device must
bear a unique device identifier (UDI), unless an exception or
alternative applies. An exception is provided for devices packaged
within the immediate container of a convenience kit, if the label of
the convenience kit bears a UDI. This guidance document describes FDA's
interpretation of the definition of ``convenience kit.'' This guidance
does not apply to in vitro diagnostic (IVD) devices that are subject to
IVD labeling requirements nor does it apply to combination products.
DATES: The announcement of the guidance is published in the Federal
Register on April 26, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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:
Guidance for Industry and Food and Drug Administration Staff;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9
[[Page 17836]]
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
``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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). 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 guidance document
entitled ``Unique Device Identification: Convenience Kits: Guidance for
Industry and Food and Drug Administration Staff; Availability'' to the
Office of Policy, 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; or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, 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 that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: For Center for Devices and
Radiological Health-regulated devices: Christina Savisaar, Unique
Device Identifier Regulatory Policy Support, 301-796-5995, email:
[email protected]. For Center for Biologics Evaluation and
Research-regulated devices: 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 guidance entitled ``Unique
Device Identification: Convenience Kits; Guidance for Industry and Food
and Drug Administration Staff.'' In the September 24, 2013, Federal
Register (78 FR 58786), FDA published a final rule establishing the
unique device identification system, which is designed to adequately
identify medical devices during their distribution and use (the UDI
Rule). Under 21 CFR 801.20, a device is required to bear a UDI on its
label and packages unless an exception or alternative applies.
Individual devices packaged within the immediate container of a
convenience kit are excepted from the UDI labeling requirements of 21
CFR 801.20, provided that a UDI is on the label of the immediate
container of the convenience kit (21 CFR 801.30(a)(11)). Convenience
kits are themselves devices.
A convenience kit is ``two or more different medical devices
packaged together for the convenience of the user'' (21 CFR 801.3). FDA
interprets this to mean a device that contains two or more different
medical devices packaged together and intended to remain packaged
together and not to be replaced, substituted, or repackaged.
Although FDA previously expressed thinking that medical procedure
kits containing only devices are convenience kits,\1\ FDA believes that
this policy requires clarification for consistency with the objective
of the unique device identification system. For purposes of the UDI
regulations, FDA does not consider every medical procedure kit, nor
every collection of two or more medical devices, to be a ``convenience
kit.''
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\1\ See 78 FR 58876 (the ``UDI Rule'') at 58800.
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FDA recognizes that the interpretation of terms provided in this
guidance may mean that fewer medical procedure kits are ``convenience
kits'' for purposes of the UDI regulations, which may impact the
assembly and packaging of medical procedure kits that are not
``convenience kits.'' Nevertheless, FDA believes that the
interpretation of the term ``convenience kit'' in this guidance
document is appropriate. As for all devices, a labeler may request an
exception from or alternative to a UDI requirement under 21 CFR 801.55.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on ``Unique Device Identification--
Convenience Kits; Guidance for Industry and Food and Drug
Administration Staff''. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statute and regulations. This guidance is not subject to
Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the 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. This
guidance documents are also available at http://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm]. Persons unable to
download an electronic copy of ``Unique Device Identification:
Convenience Kits--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
[[Page 17837]]
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in the following FDA regulations have been approved by OMB
as listed in the following table.
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OMB control
21 CFR part Topic No.
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801, subpart B, and 830........... Unique Device 0910-0720
Identification.
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Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08472 Filed 4-25-19; 8:45 am]
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