Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability, 55372-55374 [2018-24177]

Download as PDF 55372 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6841] Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect 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 guidance entitled ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.’’ This guidance describes FDA’s intention with respect to the enforcement of unique device identification requirements for class I and unclassified devices, other than implantable, life-sustaining, or lifesupporting (I/LS/LS) devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements for these devices before September 24, 2022. This guidance also describes FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as for class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022, and remain in inventory. FDA does not intend to enforce the direct mark requirements for these devices when the device’s unique device identifier (UDI) can be derived from other information directly marked on the device. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency’s good guidance practices. DATES: The announcement of the guidance is published in the Federal Register on November 5, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: VerDate Sep<11>2014 18:38 Nov 02, 2018 Jkt 247001 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– 2017–D–6841 for ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect 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 https://www.regulations.gov or at the Dockets Management Staff 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect 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 selfaddressed adhesive label to assist that office in processing your request. E:\FR\FM\05NON1.SGM 05NON1 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices FOR FURTHER INFORMATION CONTACT: For Center for Devices and Radiological Health-regulated devices: Christina Savisaar, UDI Regulatory Policy Support, 10903 New Hampshire Ave., Bldg. 66, Rm. 3319, 301–796– 5995, email: GUDIDSupport@ fda.hhs.gov. For Center of Biologics Evaluation and Research-regulated devices: Stephen Ripley, Office of Communication, Outreach, and Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911, or call 1–800–835–4709 or 240–402–8010. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.’’ On September 24, 2013, FDA published a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use (the UDI Rule). Phased implementation of the regulatory requirements set forth in that final rule is based on a series of established compliance dates based primarily on device classification, which range from September 24, 2014, to September 24, 2020. The UDI Rule requires a device to bear a unique device identifier on its label and packages unless an exception or alternative applies (see 21 CFR 801.20), and special labeling requirements apply to stand-alone software regulated as a device (21 CFR 801.50). The UDI Rule also requires that data pertaining to the key characteristics of each device required to bear a UDI be submitted to FDA’s GUDID (21 CFR 830.300). In addition, the final rule added 21 CFR 801.18, which requires certain dates on device labels to be in a standard format. For devices that: (1) Must bear UDIs on their labels and (2) are intended to be used more than once and reprocessed between uses, 21 CFR 801.45 requires the devices to be directly marked with a UDI. Compliance dates for labeling, GUDID data submission, standard date format, and direct marking requirements can be found in 78 FR 58786 at 58815 to 58816. This guidance describes FDA’s intention with regard to enforcement of labeling, standard date formatting, GUDID data submission, and direct marking for class I and unclassified devices, other than I/LS/LS devices. This guidance also describes FDA’s intention with regard to direct mark requirements for class III, LS/LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as FDA’s intention with regard to direct mark requirements for class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022, and remain in inventory. FDA considered comments received on the guidance that appeared in the Federal Register on January 16, 2018 (83 FR 2057). FDA revised the guidance as appropriate in response to the comments. This guidance supersedes the January 2018 guidance of the same name, ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.’’ This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2) (21 CFR 10.115(g)(2))). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The guidance represents the current thinking of FDA on ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.’’ It does not establish any rights for any person and 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. 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 document is also available at https://www.regulations.gov or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect 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 17029 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. 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 the following FDA regulations have been approved by OMB as listed in the following table: OMB control No. 21 CFR part Topic 801 subpart B and 830 ............. 820 ............................................ Unique Device Identification ......................................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..................... VerDate Sep<11>2014 18:38 Nov 02, 2018 Jkt 247001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 55373 E:\FR\FM\05NON1.SGM 05NON1 0910–0720 0910–0073 55374 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 31, 2018. Leslie Kux, Associate Commissioner for Policy. Dated: October 30, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–24177 Filed 11–2–18; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2018–24102 Filed 11–2–18; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel ‘‘Vaccine Adjuvant Discovery Program’’. Date: November 28–29, 2018. Time: 12:30 p.m. to 6:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Geetanjali Bansal, Ph.D., Scientific Reviewer Officer, Scientific Review Program, Division of Extramural Activities, Room 3G49, National Institutes of Health/ NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892–9834, (240) 669–5073, geetanjali.bansal@nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Clinical Trial Implementation Cooperative Agreement (U01). Date: November 29, 2018. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Kumud K. Singh, Ph.D., Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–9823, Rockville, MD 20852, 301–761–7830, kumud.singh@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, VerDate Sep<11>2014 18:38 Nov 02, 2018 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; NIH Office of Intramural Training & Education—Application, Registration, and Alumni Systems, Office of the Director AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of Intramural Training & Education (OITE) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. SUMMARY: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Patricia Wagner, Program Analyst, Office of Intramural Training & Education (OITE), Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH); 2 Center Drive: Building 2/Room 2E06; Bethesda, Maryland 20892 or call non-toll-free number 240–476–3619 or Email your request, including your address to: wagnerpa@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: NIH Office of Intramural Training & Education— Application, Registration, and Alumni Systems, 0925–0299, 06/30/2019, REVISION, Office of Intramural Training & Education (OITE), Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The Office of Intramural Training & Education (OITE) administers a variety of programs and initiatives to recruit pre-college through pre-doctoral educational level individuals into the National Institutes of Health Intramural Research Program (NIH–IRP) to facilitate their development into future biomedical scientists. The proposed information collection is necessary in order to determine the eligibility and quality of potential awardees for traineeships in these programs. The applications for admission consideration solicit information including: Personal information, ability to meet eligibility criteria, contact information, universityassigned student identification number, training program selection, scientific discipline interests, educational history, standardized examination scores, reference information, resume components, employment history, employment interests, dissertation research details, letters of recommendation, financial aid history, sensitive data, and travel information, as well as feedback questions about interviews and application submission experiences. Sensitive data collected on the applicants: Race, gender, ethnicity, relatives at NIH, and recruitment method, are made available only to OITE staff members or in aggregate form to select NIH offices and are not used by the admission committees for admission consideration. In addition, information to monitor trainee placement after departure from NIH is periodically collected. OMB approval is requested for 3 years. There are no costs to respondents E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Notices]
[Pages 55372-55374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24177]



[[Page 55372]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6841]


Unique Device Identification: Policy Regarding Compliance Dates 
for Class I and Unclassified Devices and Certain Devices Requiring 
Direct Marking; Immediately in Effect 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 guidance entitled ``Unique Device Identification: 
Policy Regarding Compliance Dates for Class I and Unclassified Devices 
and Certain Devices Requiring Direct Marking; Immediately in Effect 
Guidance for Industry and Food and Drug Administration Staff.'' This 
guidance describes FDA's intention with respect to the enforcement of 
unique device identification requirements for class I and unclassified 
devices, other than implantable, life-sustaining, or life-supporting 
(I/LS/LS) devices. FDA does not intend to enforce standard date 
formatting, labeling, and Global Unique Device Identification Database 
(GUDID) data submission requirements for these devices before September 
24, 2020. In addition, FDA does not intend to enforce direct mark 
requirements for these devices before September 24, 2022. This guidance 
also describes FDA's direct mark compliance policy for class III, LS/
LS, and class II devices that are nonsterile, manufactured and labeled 
prior to their applicable direct mark compliance date, and remain in 
inventory, as well as for class I and unclassified devices that are 
nonsterile, manufactured and labeled prior to September 24, 2022, and 
remain in inventory. FDA does not intend to enforce the direct mark 
requirements for these devices when the device's unique device 
identifier (UDI) can be derived from other information directly marked 
on the device. The guidance document is immediately in effect, but it 
remains subject to comment in accordance with the Agency's good 
guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on November 5, 2018.

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-2017-D-6841 for ``Unique Device Identification: Policy Regarding 
Compliance Dates for Class I and Unclassified Devices and Certain 
Devices Requiring Direct Marking; Immediately in Effect 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 https://www.regulations.gov or at the Dockets Management Staff 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 
``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: Policy Regarding Compliance Dates for 
Class I and Unclassified Devices and Certain Devices Requiring Direct 
Marking; Immediately in Effect 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.

[[Page 55373]]


FOR FURTHER INFORMATION CONTACT: 
    For Center for Devices and Radiological Health-regulated devices: 
Christina Savisaar, UDI Regulatory Policy Support, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3319, 301-796-5995, email: 
[email protected].
    For Center of Biologics Evaluation and Research-regulated devices: 
Stephen Ripley, Office of Communication, Outreach, and Development, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911, or call 1-800-835-
4709 or 240-402-8010.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Unique 
Device Identification: Policy Regarding Compliance Dates for Class I 
and Unclassified Devices and Certain Devices Requiring Direct Marking; 
Immediately in Effect Guidance for Industry and Food and Drug 
Administration Staff.'' On September 24, 2013, FDA published a final 
rule establishing a unique device identification system designed to 
adequately identify devices through distribution and use (the UDI 
Rule). Phased implementation of the regulatory requirements set forth 
in that final rule is based on a series of established compliance dates 
based primarily on device classification, which range from September 
24, 2014, to September 24, 2020.
    The UDI Rule requires a device to bear a unique device identifier 
on its label and packages unless an exception or alternative applies 
(see 21 CFR 801.20), and special labeling requirements apply to stand-
alone software regulated as a device (21 CFR 801.50). The UDI Rule also 
requires that data pertaining to the key characteristics of each device 
required to bear a UDI be submitted to FDA's GUDID (21 CFR 830.300). In 
addition, the final rule added 21 CFR 801.18, which requires certain 
dates on device labels to be in a standard format. For devices that: 
(1) Must bear UDIs on their labels and (2) are intended to be used more 
than once and reprocessed between uses, 21 CFR 801.45 requires the 
devices to be directly marked with a UDI. Compliance dates for 
labeling, GUDID data submission, standard date format, and direct 
marking requirements can be found in 78 FR 58786 at 58815 to 58816.
    This guidance describes FDA's intention with regard to enforcement 
of labeling, standard date formatting, GUDID data submission, and 
direct marking for class I and unclassified devices, other than I/LS/LS 
devices. This guidance also describes FDA's intention with regard to 
direct mark requirements for class III, LS/LS, and class II devices 
that are nonsterile, manufactured and labeled prior to their applicable 
direct mark compliance date, and remain in inventory, as well as FDA's 
intention with regard to direct mark requirements for class I and 
unclassified devices that are nonsterile, manufactured and labeled 
prior to September 24, 2022, and remain in inventory.
    FDA considered comments received on the guidance that appeared in 
the Federal Register on January 16, 2018 (83 FR 2057). FDA revised the 
guidance as appropriate in response to the comments. This guidance 
supersedes the January 2018 guidance of the same name, ``Unique Device 
Identification: Policy Regarding Compliance Dates for Class I and 
Unclassified Devices; Immediately in Effect Guidance for Industry and 
Food and Drug Administration Staff.''
    This guidance is being implemented without prior public comment 
because the Agency has determined that prior public participation is 
not feasible or appropriate (Sec.  10.115(g)(2) (21 CFR 10.115(g)(2))). 
FDA has determined that this guidance document presents a less 
burdensome policy that is consistent with public health. Although this 
guidance is immediately in effect, FDA will consider all comments 
received and revise the guidance document as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA on ``Unique Device Identification: Policy 
Regarding Compliance Dates for Class I and Unclassified Devices and 
Certain Devices Requiring Direct Marking.'' It does not establish any 
rights for any person and 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. 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 document is 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: Policy 
Regarding Compliance Dates for Class I and Unclassified Devices and 
Certain Devices Requiring Direct Marking; Immediately in Effect 
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 17029 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
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 Identification....................       0910-0720
820...........................................  Current Good Manufacturing Practice (CGMP);            0910-0073
                                                 Quality System (QS) Regulation.
----------------------------------------------------------------------------------------------------------------



[[Page 55374]]

    Dated: October 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24177 Filed 11-2-18; 8:45 am]
 BILLING CODE 4164-01-P