Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff; Availability, 17835-17837 [2019-08472]

Download as PDF 17835 Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices or sales for the most recent year, in both the local currency and in U.S. dollars, and the exchange rate used in converting local currency to U.S. dollars; (4) provide the dates during which the reported receipts or sales were collected; and (5) bear the official seal of the national taxing authority. Forms FDA 3602 and FDA 3602A are accessible through the guidance document entitled ‘‘Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Form FDA 3602A, FDA also believes that it will take each respondent 1 hour to complete. In the Federal Register of November 14, 2018 (83 FR 56852), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Food and Drug Administration Staff and Foreign Governments’’ on the internet at: https://www.fda.gov/ucm/groups/ fdagov-public/@fdagov-meddev-gen/ documents/document/ucm456779.pdf. The estimated burden is based on the number of applications received in the last 3 years and includes time required to collect the required information. Based on our experience with Form FDA 3602, FDA believes it will take each respondent 1 hour to complete the form. Based on our experience with TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents FDA form No. Total annual responses Average burden per response Total hours FDA 3602—MDUFA Small Business Certification Request for a Business Headquartered in the United States ........ FDA 3602A—MDUFA Foreign Small Business Certification Request for a Business Headquartered Outside the United States .................................................................... 5,000 1 5,000 1 5,000 2,000 1 2,000 1 2,000 Total .......................................................................... ........................ ........................ ........................ ........................ 7,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall increase of 2,000 hours and a corresponding increase of 2,000 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Dated: April 23, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–08471 Filed 4–25–19; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: amozie on DSK9F9SC42PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 17:28 Apr 25, 2019 Jkt 247001 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 E:\FR\FM\26APN1.SGM 26APN1 amozie on DSK9F9SC42PROD with NOTICES 17836 Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices 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/201523389.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 VerDate Sep<11>2014 17:28 Apr 25, 2019 Jkt 247001 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 Center for Devices and Radiological Health-regulated devices: Christina Savisaar, Unique Device Identifier Regulatory Policy Support, 301–796– 5995, email: GUDIDSupport@ fda.hhs.gov. 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: FOR FURTHER INFORMATION CONTACT: 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 1 See PO 00000 78 FR 58876 (the ‘‘UDI Rule’’) at 58800. Frm 00065 Fmt 4703 Sfmt 4703 consider every medical procedure kit, nor every collection of two or more medical devices, to be a ‘‘convenience kit.’’ 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance documents are also available at https://www.regulations.gov or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/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 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 E:\FR\FM\26APN1.SGM 26APN1 Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices amozie on DSK9F9SC42PROD with NOTICES 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. considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the OMB control 21 CFR part Topic No. following way: • Federal eRulemaking Portal: 801, subpart Unique De0910–0720 https://www.regulations.gov. Follow the B, and 830. vice Identiinstructions for submitting comments. fication. Comments submitted electronically, including attachments, to https:// Dated: April 23, 2019. www.regulations.gov will be posted to Lowell J. Schiller, the docket unchanged. Because your Principal Associate Commissioner for Policy. comment will be made public, you are [FR Doc. 2019–08472 Filed 4–25–19; 8:45 am] solely responsible for ensuring that your comment does not include any BILLING CODE P confidential information that you or a third party may not wish to be posted, DEPARTMENT OF HEALTH AND such as medical information, your or HUMAN SERVICES anyone else’s Social Security number, or confidential business information, such Food and Drug Administration as a manufacturing process. Please note that if you include your name, contact [Docket No. FDA–2013–N–0375] information, or other information that Agency Information Collection identifies you in the body of your Activities; Proposed Collection; comments, that information will be Comment Request; Agreement for posted on https://www.regulations.gov. Shipment of Devices for Sterilization • If you want to submit a comment with confidential information that you AGENCY: Food and Drug Administration, do not wish to be made available to the HHS. public, submit the comment as a ACTION: Notice. written/paper submission and in the manner detailed (see ‘‘Written/Paper SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). Administration (FDA or Agency) is announcing an opportunity for public Written/Paper Submissions comment on the proposed collection of Submit written/paper submissions as certain information by the Agency. follows: Under the Paperwork Reduction Act of • Mail/Hand Delivery/Courier (for 1995 (PRA), Federal Agencies are written/paper submissions): Dockets required to publish notice in the Management Staff (HFA–305), Food and Federal Register concerning each Drug Administration, 5630 Fishers proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852. including each proposed extension of an • For written/paper comments existing collection of information, and submitted to the Dockets Management to allow 60 days for public comment in Staff, FDA will post your comment, as response to the notice. This notice well as any attachments, except for solicits comments on information information submitted, marked and collection requirements relating to identified, as confidential, if submitted shipment of nonsterile devices that are as detailed in ‘‘Instructions.’’ to be sterilized elsewhere or are shipped Instructions: All submissions received to other establishments for further must include the Docket No. FDA– processing, labeling, or repacking. 2013–N–0375 for ‘‘Agreement for DATES: Submit either electronic or Shipment of Devices for Sterilization.’’ written comments on the collection of Received comments, those filed in a information by June 25, 2019. timely manner (see ADDRESSES), will be ADDRESSES: You may submit comments placed in the docket and, except for as follows. Please note that late, those submitted as ‘‘Confidential untimely filed comments will not be Submissions,’’ publicly viewable at considered. Electronic comments must https://www.regulations.gov or at the be submitted on or before June 25, 2019. Dockets Management Staff between 9 The https://www.regulations.gov a.m. and 4 p.m., Monday through electronic filing system will accept Friday. comments until 11:59 p.m. Eastern Time • Confidential Submissions—To at the end of June 25, 2019. Comments submit a comment with confidential received by mail/hand delivery/courier information that you do not wish to be (for written/paper submissions) will be made publicly available, submit your VerDate Sep<11>2014 17:28 Apr 25, 2019 Jkt 247001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 17837 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/201523389.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. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an E:\FR\FM\26APN1.SGM 26APN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.''
---------------------------------------------------------------------------

    \1\ See 78 FR 58876 (the ``UDI Rule'') at 58800.
---------------------------------------------------------------------------

    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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance documents are also available at https://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.

------------------------------------------------------------------------
                                                            OMB control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
801, subpart B, and 830...........  Unique Device              0910-0720
                                     Identification.
------------------------------------------------------------------------


    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

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