[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Rules and Regulations]
[Pages 2057-2059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00550]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

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


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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance for industry and FDA Staff entitled 
``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 
describes FDA's intention with respect to the enforcement of unique 
device identification requirements for certain class I and unclassified 
devices. FDA does not intend to enforce standard date formatting, 
labeling, and Global Unique Device Identification Database (GUDID) data 
submission requirements under Agency regulations for these devices 
before September 24, 2020. In addition, FDA does not intend to enforce 
direct mark requirements under an Agency regulation for these devices 
before September 24, 2022. The policy described in this guidance does 
not apply to implantable, life-supporting, or life-sustaining devices. 
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 January 16, 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; 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; 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; 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: Loretta Chi, Unique Device 
Identifier Regulatory Policy Support, 301-796-5995, email: 
[email protected]. For Center

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for 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; Immediately in Effect 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 
a unique device identification system designed to adequately identify 
medical devices during their distribution and use (the UDI Rule). Under 
Sec.  801.20 (21 CFR 801.20) a device is required to bear a unique 
device identifier (UDI) on its label and packages unless an exception 
or alternative applies. Special labeling requirements apply to stand-
alone software regulated as a device (Sec.  801.50 (21 CFR 801.50)). 
Under Sec.  830.300 (21 CFR 830.300) data pertaining to the key 
characteristics of each device required to bear a UDI must be submitted 
to the GUDID. Devices that must bear UDIs on their labels and that are 
intended to be used more than once and reprocessed between uses must be 
directly marked with a UDI (Sec.  801.45 (21 CFR 801.45)). In addition, 
Sec.  801.18 (21 CFR 801.18) requires certain dates on device labels to 
be in a standard format.
    UDI requirements are being phased in over 7 years according to a 
schedule of compliance dates established in the UDI Rule ranging from 
September 24, 2014, to September 24, 2020. The compliance dates 
established for class I and unclassified devices--other than 
implantable, life-supporting, or life-sustaining (I/LS/LS) devices--are 
September 24, 2018, for labeling, GUDID submission, and standard date 
format requirements, and September 24, 2020, for direct mark 
requirements.
    FDA does not intend to enforce standard date formatting, UDI 
labeling, and GUDID data submission requirements under Sec. Sec.  
801.18, 801.20, 801.50, and 830.300 for class I and unclassified 
devices, other than I/LS/LS devices, before September 24, 2020. FDA 
also does not intend to enforce direct mark requirements under Sec.  
801.45 for these devices before September 24, 2022. This policy does 
not apply to class I devices that FDA has by regulation exempted from 
the good manufacturing practice requirements because such devices are 
excepted from UDI requirements (see Sec.  801.30(a)(2) (21 CFR 
801.30(a)(2))).
    In addition, finished class I and unclassified devices, other than 
I/LS/LS devices, manufactured and labeled prior to September 24, 2018, 
are excepted from UDI labeling requirements under Sec. Sec.  801.20 and 
801.50, as well as from GUDID data submission requirements for a period 
of 3 years after the established compliance date or until September 24, 
2021. (See Sec. Sec.  801.30(a)(1) and 830.300(a).) We also do not 
intend to enforce standard date format requirements under Sec.  801.18 
during that same 3-year period for finished class I and unclassified 
devices, other than I/LS/LS devices, manufactured and labeled before 
September 24, 2018.
    Pursuant to Sec.  801.30(a)(1), finished class I and unclassified 
devices, other than I/LS/LS devices, manufactured and labeled prior to 
September 24, 2018, would also be excepted from direct marking 
requirements until September 24, 2021. However, with the exception of 
I/LS/LS devices, we do not intend to enforce direct mark requirements 
before September 24, 2022, for class I and unclassified devices 
(including those manufactured and labeled prior to September 24, 2018). 
We believe this policy regarding direct mark compliance dates is 
appropriate because it is not in the best interest of the public health 
for labelers of class I and unclassified devices to prioritize 
remediating devices in inventory to meet direct mark requirements prior 
to addressing direct marking, and its impact on the safety and 
effectiveness, for devices manufactured following labelers' full 
implementation of UDI.
    Fully realizing the benefits of the unique device identification 
system depends on UDI being integrated into data sources throughout our 
health care system, including in the supply chain, electronic health 
records, and registries. This requires UDI data to be of a high quality 
such that all stakeholders in the health care community have sufficient 
confidence in the accuracy and completeness of that data.
    To fully reap the public health benefits and a return on investment 
of the unique device identification system, the Agency intends to focus 
its resources on addressing existing implementation challenges and 
optimizing the quality and utility of UDI data for higher-risk devices 
before focusing on UDI implementation issues for lower-risk devices. 
Undertaking this endeavor now will help ensure the transition from 
development of the unique device identification system to widespread 
use and sustainability.
    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; 
Immediately in Effect Guidance for Industry and Food and Drug 
Administration Staff.'' 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. A search 
capability for all Center for Biologics Evaluation and Research 
guidance documents is available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of 
``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'' 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.

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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 21 CFR part 801 have been approved under 
OMB control number 0910-0485 and the collections of information in 21 
CFR part 830 have been approved under OMB control number 0910-0720.

    Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00550 Filed 1-12-18; 8:45 am]
 BILLING CODE 4164-01-P