[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]
 BILLING CODE P