Document ID: FDA-2016-D-0199-0026
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2021-05-21T04:00Z

[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, 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, 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)).
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

    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 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:

[[Page 27631]]

------------------------------------------------------------------------
                                                           OMB  control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
801, subpart B, and 830........  Unique Device                 0910-0720
                                  Identification.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
------------------------------------------------------------------------

    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