82 FR 54387 - Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 221 (November 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54387-54388 | |
| FR Document | 2017-24992 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Pages 54387-54388] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24992] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2245] Unique Device Identification: Direct Marking of Devices; 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 the guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' This document is intended to clarify when direct marking of devices with a unique device identifier (UDI) is required, and to assist industry and FDA staff in understanding direct marking requirements. DATES: The announcement of the guidance is published in the Federal Register on November 17, 2017. 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-2015-D-2245 for ``Unique Device Identification: Direct Marking of Devices.'' 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: Direct Marking of Devices'' 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 Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993- 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Christina Savisaar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002, 301- 496-6404, email: [email protected]. SUPPLEMENTARY INFORMATION: [[Page 54388]] I. Background Section 801.45 (21 CFR 801.45) requires a device to be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. However, ``intended to be used more than once'' and ``intended to be reprocessed'' are not defined in the UDI regulations. This guidance provides FDA's interpretation of these terms, clarifies when direct marking of devices with a UDI is required, provides recommendations for how labelers should comply with the UDI direct marking requirements, and clarifies the criteria for exceptions to the direct marking requirement. In the Federal Register of June 26, 2015, FDA published the notice of availability of ``Draft Guidance for Industry and Food and Drug Administration Staff: Unique Device Identification: Direct Marking of Devices'' (80 FR 36821) (the ``Draft Guidance''). In the notice of availability, FDA also solicited feedback on two questions related to interpretation of ``intended to be reprocessed'': (1) Should the definition of ``reprocessing'' for purposes of UDI direct marking requirements include cleaning alone without subsequent disinfection and/or sterilization of the device? and (2) what public health benefits would be served by requiring a UDI direct marking to be affixed to devices intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization? Interested persons were invited to comment by September 24, 2015. FDA considered the comments received on the draft guidance, including comments responding to the specific questions in the notice of availability, and revised the guidance as appropriate in response to these comments. II. Significance of Guidance 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: Direct Marking of 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. 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. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``Unique Device Identification: Direct Marking of Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400031 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 830 pertaining to GUDID labeler accounts and data submissions addressed in this draft guidance document have been approved under OMB control number 0910-0720. Dated: November 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-24992 Filed 11-16-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54387
Federal Register of November 3, 2017. Comments submitted electronically, redacted/blacked out, will be available
The document announced the including attachments, to https://www. for public viewing and posted on
availability of a draft guidance for regulations.gov will be posted to the https://www.regulations.gov. Submit
industry. The document was published docket unchanged. Because your both copies to the Dockets Management
with the incorrect docket number. This comment will be made public, you are Staff. If you do not wish your name and
document corrects that error. solely responsible for ensuring that your contact information to be made publicly
FOR FURTHER INFORMATION CONTACT: Lisa comment does not include any available, you can provide this
Granger, Office of Policy, Food and Drug confidential information that you or a information on the cover sheet and not
Administration, 10903 New Hampshire third party may not wish to be posted, in the body of your comments and you
Ave. Bldg. 32, Rm. 3330, Silver Spring, such as medical information, your or must identify this information as
MD 20993–0002, 301–796–9115, anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
lisa.granger@fda.hhs.gov. confidential business information, such as ‘‘confidential’’ will not be disclosed
SUPPLEMENTARY INFORMATION: In the
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Federal Register of Friday, November 3, that if you include your name, contact and other applicable disclosure law. For
2017 (82 FR 51277), in FR Doc. 2017– information, or other information that more information about FDA’s posting
23947, the following correction is made: identifies you in the body of your of comments to public dockets, see 80
On page 51277, in the second column, comments, that information will be FR 56469, September 18, 2015, or access
in the header of the document, ‘‘[Docket posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
FDA–2014–D–1147]’’ is corrected to • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
read ‘‘[Docket No. FDA–2014–D–1167]’’. with confidential information that you 23389.pdf.
do not wish to be made available to the
Dated: November 9, 2017. public, submit the comment as a Docket: For access to the docket to
Anna K. Abram, written/paper submission and in the read background documents or the
Deputy Commissioner for Policy, Planning, manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Legislation, and Analysis. Submissions’’ and ‘‘Instructions’’). received, go to https://www.regulations.
[FR Doc. 2017–24948 Filed 11–16–17; 8:45 am]
gov and insert the docket number, found
Written/Paper Submissions in brackets in the heading of this
BILLING CODE 4164–01–P
Submit written/paper submissions as document, into the ‘‘Search’’ box and
follows: follow the prompts and/or go to the
DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for Dockets Management Staff, 5630 Fishers
HUMAN SERVICES written/paper submissions): Dockets Lane, Rm. 1061, Rockville, MD 20852.
Management Staff (HFA–305), Food and You may submit comments on any
Food and Drug Administration Drug Administration, 5630 Fishers guidance at any time (see 21 CFR
[Docket No. FDA–2015–D–2245]
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
• For written/paper comments
submitted to the Dockets Management An electronic copy of the guidance
Unique Device Identification: Direct document is available for download
Marking of Devices; Guidance for Staff, FDA will post your comment, as
well as any attachments, except for from the internet. See the
Industry and Food and Drug SUPPLEMENTARY INFORMATION section for
Administration Staff; Availability information submitted, marked and
identified, as confidential, if submitted information on electronic access to the
AGENCY: Food and Drug Administration, as detailed in ‘‘Instructions.’’ guidance. Submit written requests for a
HHS. Instructions: All submissions received single hard copy of the guidance
ACTION: Notice of availability. must include the Docket No. FDA– document entitled ‘‘Unique Device
2015–D–2245 for ‘‘Unique Device Identification: Direct Marking of
SUMMARY: The Food and Drug Identification: Direct Marking of Devices’’ to the Office of the Center
Administration (FDA or Agency) is Devices.’’ Received comments will be Director, Guidance and Policy
announcing the availability of the placed in the docket and, except for Development, Center for Devices and
guidance entitled ‘‘Unique Device those submitted as ‘‘Confidential Radiological Health, Food and Drug
Identification: Direct Marking of Submissions,’’ publicly viewable at Administration, 10903 New Hampshire
Devices.’’ This document is intended to https://www.regulations.gov or at the Ave., Bldg. 66, Rm. 5431, Silver Spring,
clarify when direct marking of devices Dockets Management Staff between 9 MD 20993–0002, or the Office of
with a unique device identifier (UDI) is a.m. and 4 p.m., Monday through Communication, Outreach, and
required, and to assist industry and FDA Friday. Development, Center for Biologics
staff in understanding direct marking • Confidential Submissions—To Evaluation and Research, Food and
requirements. submit a comment with confidential Drug Administration, 10903 New
DATES: The announcement of the information that you do not wish to be Hampshire Ave., Bldg. 71, Rm. 3128,
guidance is published in the Federal made publicly available, submit your Silver Spring, MD 20993–0002. Send
Register on November 17, 2017. comments only as a written/paper one self-addressed adhesive label to
submission. You should submit two assist that office in processing your
ADDRESSES: You may submit either
copies total. One copy will include the request.
electronic or written comments on
Agency guidances at any time as information you claim to be confidential
FOR FURTHER INFORMATION CONTACT:
with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
follows: Christina Savisaar, Center for Devices
‘‘THIS DOCUMENT CONTAINS
Electronic Submissions and Radiological Health, Food and Drug
CONFIDENTIAL INFORMATION.’’ The
Administration, 10903 New Hampshire
Submit electronic comments in the Agency will review this copy, including
Ave., Bldg. 66, Rm. 3303, Silver Spring,
following way: the claimed confidential information, in
MD 20993–0002, 301–496–6404, email:
• Federal eRulemaking Portal: its consideration of comments. The
GUDIDSupport@fda.hhs.gov.
https://www.regulations.gov. Follow the second copy, which will have the
instructions for submitting comments. claimed confidential information SUPPLEMENTARY INFORMATION:
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![54388 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices
I. Background the internet. A search capability for all 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Section 801.45 (21 CFR 801.45) Center for Devices and Radiological as amended. The grant applications and
requires a device to be directly marked Health guidance documents is available the discussions could disclose
with a UDI when the device is intended at https://www.fda.gov/MedicalDevices/ confidential trade secrets or commercial
to be used more than once and intended DeviceRegulationandGuidance/ property such as patentable material,
to be reprocessed before each use. GuidanceDocuments/default.htm. and personal information concerning
However, ‘‘intended to be used more Guidance documents are also available individuals associated with the grant
than once’’ and ‘‘intended to be at https://www.fda.gov/BiologicsBlood applications, the disclosure of which
reprocessed’’ are not defined in the UDI Vaccines/GuidanceCompliance would constitute a clearly unwarranted
regulations. This guidance provides RegulatoryInformation/default.htm or invasion of personal privacy.
FDA’s interpretation of these terms, https://www.regulations.gov. Persons Name of Committee: National Institute of
clarifies when direct marking of devices unable to download an electronic copy Mental Health Special Emphasis Panel;
with a UDI is required, provides of ‘‘Unique Device Identification: Direct Member Conflicts: Mental Health Services
recommendations for how labelers Marking of Devices’’ may send an email Research.
request to CDRH-Guidance@fda.hhs.gov Date: December 7, 2017.
should comply with the UDI direct Time: 11:30 a.m. to 12:30 p.m.
marking requirements, and clarifies the to receive an electronic copy of the
Agenda: To review and evaluate grant
criteria for exceptions to the direct document. Please use the document
applications.
marking requirement. number 1400031 to identify the Place: National Institutes of Health,
In the Federal Register of June 26, guidance you are requesting. Neuroscience Center, 6001 Executive
2015, FDA published the notice of IV. Paperwork Reduction Act of 1995 Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
availability of ‘‘Draft Guidance for This guidance refers to previously Contact Person: Karen Gavin-Evans, Ph.D.,
Industry and Food and Drug approved collections of information Scientific Review Officer, Division of
Administration Staff: Unique Device described in FDA regulations. These Extramural Activities, National Institute of
Identification: Direct Marking of collections of information are subject to Mental Health, NIH, Neuroscience Center,
Devices’’ (80 FR 36821) (the ‘‘Draft review by the Office of Management and 6001 Executive Boulevard, Room 6153, MSC
Guidance’’). In the notice of availability, 9606, Bethesda, MD 20892, 301–451–2356,
Budget (OMB) under the Paperwork gavinevanskm@mail.nih.gov.
FDA also solicited feedback on two Reduction Act of 1995 (44 U.S.C. 3501–
questions related to interpretation of (Catalogue of Federal Domestic Assistance
3520). The collections of information in Program No. 93.242, Mental Health Research
‘‘intended to be reprocessed’’: (1) 21 CFR part 801 have been approved Grants, National Institutes of Health, HHS)
Should the definition of ‘‘reprocessing’’ under OMB control number 0910–0485;
for purposes of UDI direct marking Dated: November 13, 2017.
the collections of information in 21 CFR
requirements include cleaning alone Melanie J. Pantoja,
part 807, subpart E, have been approved
without subsequent disinfection and/or under OMB control number 0910–0120; Program Analyst, Office of Federal Advisory
sterilization of the device? and (2) what Committee Policy.
the collections of information in 21 CFR
public health benefits would be served part 814, subparts A through E, have [FR Doc. 2017–24899 Filed 11–16–17; 8:45 am]
by requiring a UDI direct marking to be been approved under OMB control BILLING CODE 4140–01–P
affixed to devices intended to be reused number 0910–0231; the collections of
for which reprocessing instructions information in 21 CFR part 820 have
include cleaning only and not DEPARTMENT OF HEALTH AND
been approved under OMB control
disinfection and/or sterilization? HUMAN SERVICES
number 0910–0073; and the collections
Interested persons were invited to of information in 21 CFR part 830
comment by September 24, 2015. FDA National Institutes of Health
pertaining to GUDID labeler accounts
considered the comments received on and data submissions addressed in this National Heart, Lung, and Blood
the draft guidance, including comments draft guidance document have been Institute; Notice of Closed Meeting
responding to the specific questions in approved under OMB control number
the notice of availability, and revised 0910–0720. Pursuant to section 10(d) of the
the guidance as appropriate in response Federal Advisory Committee Act, as
to these comments. Dated: November 14, 2017. amended, notice is hereby given of a
Leslie Kux, meeting of the NHLBI Institutional
II. Significance of Guidance Associate Commissioner for Policy. Training Mechanism Review
This guidance is being issued [FR Doc. 2017–24992 Filed 11–16–17; 8:45 am] Committee.
consistent with FDA’s good guidance BILLING CODE 4164–01–P The meeting will be closed to the
practices regulation (21 CFR 10.115). public in accordance with the
The guidance represents the current provisions set forth in sections
thinking of FDA on ‘‘Unique Device DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Identification: Direct Marking of HUMAN SERVICES as amended. The grant applications and
Devices.’’ It does not establish any rights the discussions could disclose
for any person and is not binding on National Institutes of Health confidential trade secrets or commercial
FDA or the public. You can use an property such as patentable material,
National Institute of Mental Health;
alternative approach if it satisfies the and personal information concerning
Notice of Closed Meeting
sradovich on DSK3GMQ082PROD with NOTICES
requirements of the applicable statutes individuals associated with the grant
and regulations. This guidance is not Pursuant to section 10(d) of the applications, the disclosure of which
subject to Executive Order 12866. Federal Advisory Committee Act, as would constitute a clearly unwarranted
amended, notice is hereby given of the invasion of personal privacy.
III. Electronic Access
following meeting. Name of Committee: Heart, Lung, and
Persons interested in obtaining a copy The meeting will be closed to the Blood Initial Review Group; NHLBI
of the guidance may do so by public in accordance with the Institutional Training Mechanism Review
downloading an electronic copy from provisions set forth in sections Committee.
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Document Created: 2017-11-17 05:14:38
Document Modified: 2017-11-17 05:14:38
| 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 17, 2017. | |
| Contact | Christina Savisaar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002, 301- 496-6404, email: [email protected] | |
| FR Citation | 82 FR 54387 |
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