Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages; Guidance for Industry and Food and Drug Administration Staff; Availability, 27629-27631 [2021-10752]
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Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
represent the current thinking of FDA
on ‘‘Adjusting for Covariates in
Randomized Clinical Trials for Drugs
and Biologics.’’ 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.
II. Paperwork Reduction Act of 1995
While this draft guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR 312.23 for the
content and format of investigational
new drug applications have been
approved under OMB control number
0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: May 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10760 Filed 5–20–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0199]
Enforcement Policy Regarding Use of
National Health Related Item Code and
National Drug Code Numbers on
Device Labels and Packages;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Enforcement Policy
Regarding Use of National Health
Related Item Code and National Drug
SUMMARY:
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
Code Numbers on Device Labels and
Packages.’’ This guidance describes the
Agency’s policy regarding the
prohibition against providing National
Health Related Item Code (NHRIC) and
National Drug Code (NDC) numbers on
device labels and device packages set
forth in FDA regulations. As described
in the guidance, FDA does not intend to
object to the use of FDA legacy
identification numbers on device labels
and packages for finished devices
manufactured and labeled prior to
September 24, 2023. The guidance 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 May 21, 2021.
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
PO 00000
Frm 00078
Fmt 4703
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27629
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–
2016–D–0199 for ‘‘Enforcement Policy
Regarding Use of National Health
Related Item Code and National Drug
Code Numbers on Device Labels and
Packages; 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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
E:\FR\FM\21MYN1.SGM
21MYN1
27630
Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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 ‘‘Enforcement Policy
Regarding Use of National Health
Related Item Code and National Drug
Code Numbers on Device Labels and
Packages; Guidance for Industry and
Food and Drug Administration Staff’’ 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 Center for
Biologics Evaluation and Research,
Office of Communication, Outreach, and
Development, 10903 New Hampshire
Ave., Bldg. 71, Rm. 3128, Silver Spring,
MD 20903. Send one self-addressed
adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT:
Steven Luxenberg, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3216, Silver Spring,
MD 20993–0002, 301–796–7043,
steven.luxenberg@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 226 of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) and section 614
of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112–
144) amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) to add
section 519(f) (21 U.S.C. 360i(f)), which
directs FDA to issue regulations
establishing a unique device
identification system for medical
devices along with implementation
timeframes for certain medical devices.
The final rule (UDI Rule), establishing
the unique device identification system,
was published on September 24, 2013
(78 FR 58786).
Prior to the establishment of the
FDA’s unique device identification
system, the absence of a standardized,
1 Although § 801.57 rescinds any NHRIC or NDC
‘‘assigned’’ to a device, such NDC numbers are not
assigned in compliance with 21 CFR 207.33. Rather,
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
unique identification system for devices
led some companies to obtain a labeler
code from FDA and place NHRIC or
NDC numbers on the labels and
packages of certain medical devices. In
recognition of this practice, and to
further the objectives of the unique
device identification program, the UDI
Rule includes a provision that rescinds
any NHRIC or NDC number, assigned to
a medical device.1 Under § 801.57(a) (21
CFR 801.57(a)), on the date a device is
required to bear a UDI on its label, any
NHRIC or NDC number assigned to that
device is rescinded and may no longer
be on the device label or on any device
package. If a device is not required to
bear a UDI on its label, any NHRIC or
NDC number assigned to that device is
rescinded as of September 24, 2018, and
may no longer be on the device label or
on any device package (§ 801.57(b)).
For the reasons described in the
guidance, we believe that extending the
policy for a limited additional time as
stakeholders continue to make changes
to transition medical device
reimbursement, supply chain, and
procurement systems and processes
away from use of legacy NHRIC and
NDC numbers is appropriate and in the
interest of the public health.
By September 24, 2023, more devices
will bear UDIs, and we anticipate
reimbursement, supply chain, and
procurement systems will be better
prepared to rely on UDIs. We also
intend to work to encourage UDI
adoption throughout healthcare data
systems, including in those that
currently rely on NHRIC and NDC
numbers to help facilitate a smooth
transition away from use of these legacy
identifiers on device labels and fully
realize the benefits of UDI. Additionally,
the guidance addresses requests for
continued use of a previously assigned
FDA labeler code under a system for the
issuance of UDIs.
This guidance is being implemented
without prior public comment because
the Agency has determined that prior
public participation is not feasible or
appropriate (see section 701(h)(1)(C) of
the FD&C Act (21 U.S.C. 371(h)(1)(C))
and 21 CFR 10.115(g)(2)). FDA has
determined that this guidance 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.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Enforcement
Policy Regarding Use of National Health
Related Item Code and National Drug
Code Numbers on Device Labels and
Packages; 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.
some device manufacturers had labeler codes
previously assigned to them by FDA, which they
used to create numbers that were labeled as
‘‘NHRIC’’ or ‘‘NDC.’’
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
II. 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/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov and at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. Persons
unable to download an electronic copy
of ‘‘Enforcement Policy Regarding Use
of National Health Related Item Code
and National Drug Code Numbers on
Device Labels and Packages; 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 GUD1500044 and
complete title to identify the guidance
you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
E:\FR\FM\21MYN1.SGM
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Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
Topic
801, subpart B, and 830 ...........................
800, 801, and 809 ....................................
Unique Device Identification ........................................................................................
Medical Device Labeling Regulations ..........................................................................
[FR Doc. 2021–10752 Filed 5–20–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0268]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Labeling of Certain
Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of the
recommended labeling of certain beers
subject to our labeling jurisdiction.
DATES: Submit either electronic or
written comments on the collection of
information by July 20, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 20, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 20, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
OMB
control No.
21 CFR part
Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
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–
2009–D–0268 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Labeling
of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
27631
0910–0720
0910–0485
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Notices]
[Pages 27629-27631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10752]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0199]
Enforcement Policy Regarding Use of National Health Related Item
Code and National Drug Code Numbers on Device Labels and Packages;
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 ``Enforcement Policy
Regarding Use of National Health Related Item Code and National Drug
Code Numbers on Device Labels and Packages.'' This guidance describes
the Agency's policy regarding the prohibition against providing
National Health Related Item Code (NHRIC) and National Drug Code (NDC)
numbers on device labels and device packages set forth in FDA
regulations. As described in the guidance, FDA does not intend to
object to the use of FDA legacy identification numbers on device labels
and packages for finished devices manufactured and labeled prior to
September 24, 2023. The guidance 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 May 21, 2021.
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-2016-D-0199 for ``Enforcement Policy Regarding Use of National
Health Related Item Code and National Drug Code Numbers on Device
Labels and Packages; 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, 240-
402-7500.
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.govinfo.gov/content/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, 240-402-7500.
[[Page 27630]]
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
``Enforcement Policy Regarding Use of National Health Related Item Code
and National Drug Code Numbers on Device Labels and Packages; Guidance
for Industry and Food and Drug Administration Staff'' 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 Center
for Biologics Evaluation and Research, Office of Communication,
Outreach, and Development, 10903 New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20903. Send one self-addressed adhesive label
to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Steven Luxenberg, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3216, Silver Spring, MD 20993-0002, 301-
796-7043, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 226 of the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85) and section 614 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144) amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) to add section 519(f)
(21 U.S.C. 360i(f)), which directs FDA to issue regulations
establishing a unique device identification system for medical devices
along with implementation timeframes for certain medical devices. The
final rule (UDI Rule), establishing the unique device identification
system, was published on September 24, 2013 (78 FR 58786).
Prior to the establishment of the FDA's unique device
identification system, the absence of a standardized, unique
identification system for devices led some companies to obtain a
labeler code from FDA and place NHRIC or NDC numbers on the labels and
packages of certain medical devices. In recognition of this practice,
and to further the objectives of the unique device identification
program, the UDI Rule includes a provision that rescinds any NHRIC or
NDC number, assigned to a medical device.\1\ Under Sec. 801.57(a) (21
CFR 801.57(a)), on the date a device is required to bear a UDI on its
label, any NHRIC or NDC number assigned to that device is rescinded and
may no longer be on the device label or on any device package. If a
device is not required to bear a UDI on its label, any NHRIC or NDC
number assigned to that device is rescinded as of September 24, 2018,
and may no longer be on the device label or on any device package
(Sec. 801.57(b)).
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\1\ Although Sec. 801.57 rescinds any NHRIC or NDC ``assigned''
to a device, such NDC numbers are not assigned in compliance with 21
CFR 207.33. Rather, some device manufacturers had labeler codes
previously assigned to them by FDA, which they used to create
numbers that were labeled as ``NHRIC'' or ``NDC.''
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For the reasons described in the guidance, we believe that
extending the policy for a limited additional time as stakeholders
continue to make changes to transition medical device reimbursement,
supply chain, and procurement systems and processes away from use of
legacy NHRIC and NDC numbers is appropriate and in the interest of the
public health.
By September 24, 2023, more devices will bear UDIs, and we
anticipate reimbursement, supply chain, and procurement systems will be
better prepared to rely on UDIs. We also intend to work to encourage
UDI adoption throughout healthcare data systems, including in those
that currently rely on NHRIC and NDC numbers to help facilitate a
smooth transition away from use of these legacy identifiers on device
labels and fully realize the benefits of UDI. Additionally, the
guidance addresses requests for continued use of a previously assigned
FDA labeler code under a system for the issuance of UDIs.
This guidance is being implemented without prior public comment
because the Agency has determined that prior public participation is
not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act
(21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). FDA has determined
that this guidance 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.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Enforcement Policy Regarding Use of
National Health Related Item Code and National Drug Code Numbers on
Device Labels and Packages; 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.
II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download
an electronic copy of ``Enforcement Policy Regarding Use of National
Health Related Item Code and National Drug Code Numbers on Device
Labels and Packages; 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 GUD1500044 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:
[[Page 27631]]
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OMB control
21 CFR part Topic No.
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801, subpart B, and 830........ Unique Device 0910-0720
Identification.
800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
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Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10752 Filed 5-20-21; 8:45 am]
BILLING CODE 4164-01-P
