[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5760-5762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0199]


Enforcement Policy on National Health Related Item Code and 
National Drug Code Numbers Assigned to Devices; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability and 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance for industry and FDA staff entitled 
``Enforcement Policy on National Health Related Item Code and National 
Drug Code Numbers Assigned to Devices.'' When finalized, this draft 
document will describe the Agency's intent not to enforce, before 
September 24, 2021, the prohibition against providing National Health 
Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device 
labels and device packages, with respect to certain finished devices 
manufactured and labeled prior to September 24, 2018. In addition, when 
finalized, this draft guidance will describe the Agency's intent to 
continue considering requests for continued use of FDA labeler codes 
under a system for the issuance of unique device identifiers (UDIs) 
until September 24, 2018. This draft guidance is not the final version 
of the guidance nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 4, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 on National Health Related 
Item Code and National Drug Code Numbers Assigned to Devices.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the draft 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 draft guidance document entitled 
``Enforcement Policy on National Health Related Item Code and National 
Drug Code Numbers Assigned to Devices'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. 
Alternatively, you may submit written

[[Page 5761]]

requests for a single copy of the draft guidance to the Office of 
Communications, Outreach, and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to the office that you are ordering 
from to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: UDI Regulatory Policy Support, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave. Bldg. 66, Rm. 3303, Silver Spring, MD 20993-
0002, 301-796-5995, email: [email protected].

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 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). Among other 
requirements, the UDI Rule requires that the label and every device 
package of a medical device distributed in the United States bear a 
UDI, unless an exception or alternative applies (21 CFR 801.20).
    The unique device identification system is being phased in over 
seven years according to a series of compliance dates, based primarily 
on device classification. These compliance dates establish the dates 
after which devices placed into commercial distribution must bear a UDI 
on their labels and device packages as follows: September 24, 2014, for 
Class III devices and devices licensed under the Public Health Service 
Act (PHS Act); September 24, 2015, for implantable, life-supporting, or 
life-sustaining devices; September 24, 2016, for Class II devices; and 
September 24, 2018, for Class I and unclassified devices (78 FR 58786 
at 58815).
    To further the objectives of creating a national device 
identification system, the UDI Rule includes a provision that rescinds 
any NHRIC or NDC number, assigned to a medical device (21 CFR 801.57). 
Under Sec.  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. For a device 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)).
    Currently, medical devices available through a pharmacy and 
potentially eligible for reimbursement from payers are generally 
labeled with an 11-digit reimbursement number, typically using an NHRIC 
or NDC number assigned to the device. The draft guidance, when 
finalized, would describe the Agency's intent not to enforce before 
September 24, 2021, the prohibition against providing NHRIC and NDC 
numbers on device labels and device packages of finished class III 
devices; devices licensed under the PHS Act; class II devices; and 
implantable, life-supporting or life-sustaining devices that are 
manufactured and labeled prior to September 24, 2018. This timeline 
would coincide with the schedule by which remaining class I and 
unclassified devices that do not qualify for an exception or 
alternative must bear a UDI on their labels and device packages. This 
enforcement policy, when finalized, would apply to the requirements 
under Sec.  801.57(a) for class III devices; devices licensed under the 
PHS Act; class II devices; and implantable, life-supporting or life-
sustaining devices only; it would not extend to any of the other 
requirements of the UDI Rule for these devices.
    FDA believes that continued implementation of UDI requirements 
under 21 CFR 801 subpart B and 21 CFR 830 subpart E according to the 
scheduled compliance dates is important to achieving the objectives of 
the UDI Rule in a timely manner. However, it is not FDA's intent to 
cause disruption to existing reimbursement, supply chain, and 
procurement processes, or to interfere potentially with patient access 
to treatment. We therefore recognize that additional time is 
appropriate for stakeholders to make changes to ensure that medical 
device reimbursement, supply chain, and procurement systems and 
processes will not depend on NHRIC and NDC numbers.
    Additionally, under Sec.  801.57(c) and (d), a labeler may submit a 
request to FDA for continued use of a previously assigned FDA labeler 
code under a system for the issuance of UDIs. A labeler who has been 
assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers 
may continue to use that labeler code under a system for the issuance 
of UDIs provided that such use is consistent with the framework of the 
issuing Agency that operates that system and that the labeler submits, 
and obtains FDA approval of, a request for continued use of the 
assigned labeler code (Sec.  801.57(c)). Under Sec.  801.57(c)(2), the 
deadline to submit such a request is September 24, 2014.
    FDA intends to consider requests submitted to the Agency for 
continued use of an FDA labeler code under a system for the issuance of 
UDIs until September 24, 2018. In addition, FDA does not intend to take 
action against a labeler for incorporating a previously assigned FDA 
labeler code into its UDI without requesting approval to do so by the 
deadline set forth in Sec.  801.57(c)(2), if that labeler submits a 
request that otherwise complies with Sec.  801.57(c) and (d) by 
September 24, 2018. Labelers who have been granted continued use of an 
FDA labeler code by FDA should contact their FDA-accredited issuing 
Agency to incorporate the FDA labeler code into their UDIs.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Enforcement 
Policy on National Health Related Item Code and National Drug Code 
Numbers Assigned to Devices''. 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.

III. Request for Comments

    FDA is seeking additional information on this issue. FDA is 
particularly interested in receiving information relating to the 
following question:
     Is a time period through September 24, 2018, an 
appropriate amount of additional time for stakeholders to adopt medical 
device reimbursement, supply chain, and procurement systems that do not 
depend on having NHRIC and NDC numbers on the device label? If not, why 
is this not an appropriate amount of time and how much more time would 
be reasonable?

IV. Electronic Access

    Persons interested in obtaining a copy of the draft 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

[[Page 5762]]

at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of 
the draft guidance document entitled ``Enforcement Policy on National 
Health Related Item Code and National Drug Code Numbers Assigned to 
Devices'' may send an email request to [email protected] or to 
[email protected], or by calling 1-800-835-4709 or 240-402-7800, to 
receive an electronic copy of the document. Please use the document 
number GUD1500044 to identify the guidance you are requesting.

V. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information described 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 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01892 Filed 2-2-16; 8:45 am]
BILLING CODE 4164-01-P