83 FR 55372 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 214 (November 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 214 (November 5, 2018)
| Page Range | 55372-55374 | |
| FR Document | 2018-24177 |
[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)] [Notices] [Pages 55372-55374] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![55372 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices
DEPARTMENT OF HEALTH AND Electronic Submissions comments only as a written/paper
HUMAN SERVICES Submit electronic comments in the submission. You should submit two
following way: copies total. One copy will include the
Food and Drug Administration information you claim to be confidential
• Federal eRulemaking Portal:
[Docket No. FDA–2017–D–6841] https://www.regulations.gov. Follow the with a heading or cover note that states
instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Unique Device Identification: Policy Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
Regarding Compliance Dates for Class including attachments, to https:// Agency will review this copy, including
I and Unclassified Devices and Certain www.regulations.gov will be posted to the claimed confidential information, in
Devices Requiring Direct Marking; its consideration of comments. The
the docket unchanged. Because your
Immediately in Effect Guidance for second copy, which will have the
comment will be made public, you are
Industry and Food and Drug claimed confidential information
solely responsible for ensuring that your
Administration Staff; Availability redacted/blacked out, will be available
comment does not include any
for public viewing and posted on
AGENCY: Food and Drug Administration, confidential information that you or a
https://www.regulations.gov. Submit
HHS. third party may not wish to be posted,
both copies to the Dockets Management
ACTION: Notice of availability. such as medical information, your or
Staff. If you do not wish your name and
anyone else’s Social Security number, or
contact information to be made publicly
SUMMARY: The Food and Drug confidential business information, such
available, you can provide this
Administration (FDA or Agency) is as a manufacturing process. Please note information on the cover sheet and not
announcing the availability of a that if you include your name, contact in the body of your comments and you
guidance entitled ‘‘Unique Device information, or other information that must identify this information as
Identification: Policy Regarding identifies you in the body of your ‘‘confidential.’’ Any information marked
Compliance Dates for Class I and comments, that information will be as ‘‘confidential’’ will not be disclosed
Unclassified Devices and Certain posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Devices Requiring Direct Marking; • If you want to submit a comment and other applicable disclosure law. For
Immediately in Effect Guidance for with confidential information that you more information about FDA’s posting
Industry and Food and Drug do not wish to be made available to the of comments to public dockets, see 80
Administration Staff.’’ This guidance public, submit the comment as a FR 56469, September 18, 2015, or access
describes FDA’s intention with respect written/paper submission and in the the information at: https://www.gpo.gov/
to the enforcement of unique device manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
identification requirements for class I Submissions’’ and ‘‘Instructions’’). 23389.pdf.
and unclassified devices, other than
Written/Paper Submissions Docket: For access to the docket to
implantable, life-sustaining, or life-
read background documents or the
supporting (I/LS/LS) devices. FDA does Submit written/paper submissions as electronic and written/paper comments
not intend to enforce standard date follows: received, go to https://
formatting, labeling, and Global Unique • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Device Identification Database (GUDID) written/paper submissions): Dockets docket number, found in brackets in the
data submission requirements for these Management Staff (HFA–305), Food and heading of this document, into the
devices before September 24, 2020. In Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
addition, FDA does not intend to Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
enforce direct mark requirements for • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
these devices before September 24, submitted to the Dockets Management Rockville, MD 20852.
2022. This guidance also describes Staff, FDA will post your comment, as You may submit comments on any
FDA’s direct mark compliance policy well as any attachments, except for guidance at any time (see 21 CFR
for class III, LS/LS, and class II devices information submitted, marked and 10.115(g)(5)).
that are nonsterile, manufactured and identified, as confidential, if submitted An electronic copy of the guidance
labeled prior to their applicable direct as detailed in ‘‘Instructions.’’ document is available for download
mark compliance date, and remain in Instructions: All submissions received from the internet. See the
inventory, as well as for class I and must include the Docket No. FDA– SUPPLEMENTARY INFORMATION section for
unclassified devices that are nonsterile, 2017–D–6841 for ‘‘Unique Device information on electronic access to the
manufactured and labeled prior to Identification: Policy Regarding guidance. Submit written requests for a
September 24, 2022, and remain in Compliance Dates for Class I and single hard copy of the guidance
inventory. FDA does not intend to Unclassified Devices and Certain document entitled ‘‘Unique Device
enforce the direct mark requirements for Devices Requiring Direct Marking; Identification: Policy Regarding
these devices when the device’s unique Immediately in Effect Guidance for Compliance Dates for Class I and
device identifier (UDI) can be derived Industry and Food and Drug Unclassified Devices and Certain
from other information directly marked Administration Staff.’’ Received Devices Requiring Direct Marking;
on the device. The guidance document comments will be placed in the docket Immediately in Effect Guidance for
is immediately in effect, but it remains and, except for those submitted as Industry and Food and Drug
subject to comment in accordance with ‘‘Confidential Submissions,’’ publicly Administration Staff’’ to the Office of
the Agency’s good guidance practices. viewable at https://www.regulations.gov the Center Director, Guidance and
DATES: The announcement of the or at the Dockets Management Staff Policy Development, Center for Devices
guidance is published in the Federal between 9 a.m. and 4 p.m., Monday and Radiological Health, Food and Drug
Register on November 5, 2018. through Friday. Administration, 10903 New Hampshire
ADDRESSES: You may submit either • Confidential Submissions—To Ave. Bldg. 66, Rm. 5431, Silver Spring,
electronic or written comments on submit a comment with confidential MD 20993–0002. Send one self-
Agency guidances at any time as information that you do not wish to be addressed adhesive label to assist that
follows: made publicly available, submit your office in processing your request.
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![55374 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Notices
Dated: October 31, 2018. Microbiology and Infectious Diseases function of the agency, including
Leslie Kux, Research, National Institutes of Health, HHS) whether the information will have
Associate Commissioner for Policy. Dated: October 30, 2018. practical utility; (2) The accuracy of the
[FR Doc. 2018–24177 Filed 11–2–18; 8:45 am] Natasha M. Copeland, agency’s estimate of the burden of the
BILLING CODE 4164–01–P Program Analyst, Office of Federal Advisory proposed collection of information,
Committee Policy. including the validity of the
[FR Doc. 2018–24102 Filed 11–2–18; 8:45 am]
methodology and assumptions used; (3)
DEPARTMENT OF HEALTH AND Ways to enhance the quality, utility, and
BILLING CODE 4140–01–P
HUMAN SERVICES clarity of the information to be
collected; and (4) Ways to minimize the
National Institutes of Health DEPARTMENT OF HEALTH AND burden of the collection of information
HUMAN SERVICES on those who are to respond, including
National Institute of Allergy and the use of appropriate automated,
Infectious Diseases; Notice of Closed National Institutes of Health electronic, mechanical, or other
Meetings technological collection techniques or
Proposed Collection; 60-Day Comment other forms of information technology.
Pursuant to section 10(d) of the
Request; NIH Office of Intramural Proposed Collection Title: NIH Office
Federal Advisory Committee Act, as of Intramural Training & Education—
Training & Education—Application,
amended, notice is hereby given of the Application, Registration, and Alumni
Registration, and Alumni Systems,
following meetings. Systems, 0925–0299, 06/30/2019,
Office of the Director
The meetings will be closed to the REVISION, Office of Intramural
public in accordance with the AGENCY: National Institutes of Health, Training & Education (OITE), Office of
provisions set forth in sections HHS. Intramural Research (OIR), Office of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., ACTION: Notice. Director (OD), National Institutes of
as amended. The grant applications and Health (NIH).
the discussions could disclose SUMMARY: In compliance with the Need and Use of Information
confidential trade secrets or commercial requirement of the Paperwork Collection: The Office of Intramural
property such as patentable material, Reduction Act of 1995 to provide Training & Education (OITE)
and personal information concerning opportunity for public comment on administers a variety of programs and
individuals associated with the grant proposed data collection projects, the initiatives to recruit pre-college through
applications, the disclosure of which National Institutes of Health Office of pre-doctoral educational level
would constitute a clearly unwarranted Intramural Training & Education (OITE) individuals into the National Institutes
invasion of personal privacy. will publish periodic summaries of of Health Intramural Research Program
Name of Committee: National Institute of propose projects to be submitted to the (NIH–IRP) to facilitate their
Allergy and Infectious Diseases Special Office of Management and Budget development into future biomedical
Emphasis Panel ‘‘Vaccine Adjuvant (OMB) for review and approval. scientists. The proposed information
Discovery Program’’. DATES: Comments regarding this collection is necessary in order to
Date: November 28–29, 2018. information collection are best assured determine the eligibility and quality of
Time: 12:30 p.m. to 6:00 p.m. of having their full effect if received potential awardees for traineeships in
Agenda: To review and evaluate contract
within 60 days of the date of this these programs. The applications for
proposals.
Place: National Institutes of Health, 5601 publication. admission consideration solicit
Fishers Lane, Rockville, MD 20892, FOR FURTHER INFORMATION CONTACT: To information including: Personal
(Telephone Conference Call). obtain a copy of the data collection information, ability to meet eligibility
Contact Person: Geetanjali Bansal, Ph.D., plans and instruments, submit criteria, contact information, university-
Scientific Reviewer Officer, Scientific Review
comments in writing, or request more assigned student identification number,
Program, Division of Extramural Activities, training program selection, scientific
Room 3G49, National Institutes of Health/ information on the proposed project,
contact: Dr. Patricia Wagner, Program discipline interests, educational history,
NIAID, 5601 Fishers Lane, MSC 9834, standardized examination scores,
Bethesda, MD 20892–9834, (240) 669–5073, Analyst, Office of Intramural Training &
Education (OITE), Office of Intramural reference information, resume
geetanjali.bansal@nih.gov.
components, employment history,
Name of Committee: National Institute of Research (OIR), Office of the Director
employment interests, dissertation
Allergy and Infectious Diseases Special (OD), National Institutes of Health
research details, letters of
Emphasis Panel NIAID Clinical Trial (NIH); 2 Center Drive: Building 2/Room
Implementation Cooperative Agreement recommendation, financial aid history,
2E06; Bethesda, Maryland 20892 or call
(U01). sensitive data, and travel information, as
non-toll-free number 240–476–3619 or
Date: November 29, 2018. well as feedback questions about
Email your request, including your
Time: 12:00 p.m. to 3:00 p.m. interviews and application submission
address to: wagnerpa@od.nih.gov.
Agenda: To review and evaluate grant experiences. Sensitive data collected on
applications. Formal requests for additional plans and
the applicants: Race, gender, ethnicity,
Place: National Institutes of Health, 5601 instruments must be requested in
relatives at NIH, and recruitment
Fishers Lane, Rockville, MD 20892, writing.
method, are made available only to
(Telephone Conference Call). SUPPLEMENTARY INFORMATION: Section OITE staff members or in aggregate form
Contact Person: Kumud K. Singh, Ph.D., 3506(c)(2)(A) of the Paperwork
Scientific Review Officer, Scientific Review
to select NIH offices and are not used by
Program, DEA/NIAID/NIH/DHHS, 5601
Reduction Act of 1995 requires: Written the admission committees for admission
Fishers Lane, MSC–9823, Rockville, MD comments and/or suggestions from the consideration. In addition, information
20852, 301–761–7830, kumud.singh@ public and affected agencies are invited to monitor trainee placement after
nih.gov. to address one or more of the following departure from NIH is periodically
(Catalogue of Federal Domestic Assistance points: (1) Whether the proposed collected.
Program Nos. 93.855, Allergy, Immunology, collection of information is necessary OMB approval is requested for 3
and Transplantation Research; 93.856, for the proper performance of the years. There are no costs to respondents
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Document Created: 2018-11-03 00:28:18
Document Modified: 2018-11-03 00:28:18
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on November 5, 2018. | |
| 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] | |
| FR Citation | 83 FR 55372 |
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