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
| Published date | 01 July 2020 |
| Citation | 85 FR 39477 |
| Record Number | 2020-14082 |
| Section | Rules and Regulations |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 127 (Wednesday, July 1, 2020)
[Federal Register Volume 85, Number 127 (Wednesday, July 1, 2020)]
[Rules and Regulations]
[Pages 39477-39479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14082]
[[Page 39477]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[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, Health and Human Services (HHS).
ACTION: Availability of guidance.
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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 revises the guidance by the same title issued November 5,
2018, and describes FDA's intention with respect to the enforcement of
unique device identification (UDI) requirements for class I and
unclassified devices, other than implantable, life-sustaining, or life-
supporting (I/LS/LS) devices. In this revised guidance, FDA clarifies
that, at this time, in light of the considerations described in the
guidance, it 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, 2022.
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 July 1, 2020.
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, 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.
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 or the Center for Biologics
Evaluation and Research, Office of Communication, Outreach, and
Development, 10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver
Spring, MD 20903. Send one self-addressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
For Center for Devices and Radiological Health-regulated devices:
Christina Savisaar, UDI Regulatory Policy Support, 10903 New Hampshire
[[Page 39478]]
Ave., Bldg. 32, Rm. 3255, 301-796-5995, email:
[email protected].
For Center for Biologics Evaluation and Research-regulated devices:
Stephen Ripley, Office of Communication, Outreach, and Development,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911, or call 1-800-835-
4709 or 240-402-8010.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled ``Unique
Device Identification: Policy Regarding Compliance Dates for Class I
and Unclassified Devices 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 UDI 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 UDI 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 these
labeling, GUDID data submission, standard date format, and direct
marking requirements can be found in the preamble to the UDI Rule, 78
FR 58786 at 58815 to 58816.
This guidance describes FDA's intention with regard to enforcement
of these requirements for class I and unclassified devices, other than
I/LS/LS devices. This revised guidance supersedes the November 2018
guidance of the same title, ``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.'' In this
revised guidance, FDA states that, at this time, in light of the
considerations described in the guidance, it does not intend to enforce
the requirements under 21 CFR 801.18, 801.20, 801.50, and 830.300 for
class I and unclassified devices, other than I/LS/LS devices, prior to
September 24, 2022, regardless of the date they are manufactured and
labeled. The guidance explains that FDA believes it is important to
continue focusing its resources on addressing UDI implementation issues
and data quality for higher risk devices and, at this time, concludes
that continuing its existing policy with regard to enforcement of these
requirements for class I and unclassified devices, other than I/LS/LS
devices, is consistent with the public health. In addition, while some
editorial changes were made to improve clarity, other policies
described in the November 2018 guidance remain the same in the revised
guidance.
FDA considered comments received on the guidance that appeared in
the Federal Register on November 5, 2018 (83 FR 55372) as the Agency
revised the guidance.
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 Federal
Food, Drug, and Cosmetic 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 ``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.
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 or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. 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 and complete title to
identify the guidance you are requesting.
III. 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. 3501-3521). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:
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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.
820............................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
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[[Page 39479]]
Dated: June 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14082 Filed 6-30-20; 8:45 am]
BILLING CODE 4164-01-P
