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
<![CDATA[
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]]
-----------------------------------------------------------------------
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
