81 FR 48814 - Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 143 (July 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 143 (July 26, 2016)
| Page Range | 48814-48816 | |
| FR Document | 2016-17554 |
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)] [Notices] [Pages 48814-48816] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17554] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1853] Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' When finalized, this draft document will define the expected content and forms of the unique device identifier (UDI), to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). This draft guidance is not the final version of the guidance nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 26, 2016.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-1853 for ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' 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 [[Page 48815]] 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 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 ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)'' 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 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 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 protected]. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010. SUPPLEMENTARY INFORMATION: I. Background The UDI Rule, establishing the unique device identification system, was published on September 24, 2013 (78 FR 58786). The main objective of the UDI system is to adequately identify devices through distribution and use. Among other requirements, the UDI Rule requires the label and device packages of every medical device distributed in the United States to bear a UDI, unless an exception or alternative applies (21 CFR 801.20). The UDI Rule is intended to create a standardized identification system for medical devices used in the United States that makes it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. The UDI Rule specifies that the labeler, as defined under Sec. 801.3 (21 CFR 801.3), is responsible for complying with the UDI labeling (21 CFR part 801, subpart B) and Global Unique Device Identification Database (GUDID) submission (21 CFR part 830, subpart E) requirements. The UDI Rule also requires UDIs to be issued under a system operated by an FDA- accredited issuing agency (21 CFR 830.20(a)). Each labeler, therefore, must work with one or more FDA-accredited issuing agencies to develop UDIs for devices that are required to bear a UDI. In order for there to be an effective identification system, it is essential that the FDA- accredited issuing agencies develop and operate systems for the assignment of UDIs that allow labelers using these systems to be in compliance with UDI labeling requirements. In this guidance, when finalized, we describe the two forms of a UDI and clarify the content of the UDI, including the data delimiters that identify specific data elements within the UDI. The order of the data in a UDI and UDI carrier are discussed as well. The UDI, as defined under Sec. 801.3, is an identifier that adequately identifies a device through its distribution and use. A UDI is composed of: (1) A device identifier (DI), (2) typically one or more production identifiers (PIs) when included in a device label, and (3) the data delimiters for the DI and PIs included in the UDI. The regulation at Sec. 801.40(a) (21 CFR 801.40(a)) specifies that the UDI must be presented in both easily readable plain-text and automatic identification and data capture (AIDC) technology forms on the label of the device and on each device package. For those devices required to be directly marked with a UDI under 21 CFR 801.45, the UDI may be provided through either or both forms, or any alternative technology that will provide the UDI of the device on demand. ``Easily readable plain-text'' means the legible interpretation of the data characters encoded in the AIDC form of the full UDI, including the data delimiters. The easily readable plain-text form of the UDI should include the DI, any PIs, and data delimiters contained in the UDI. The UDI Rule does not require the use of specific forms of AIDC or specific AIDC technologies to present the UDI, and labelers may choose to use more than one type of AIDC technology form. The AIDC form of the UDI must be in a format that can be read by a bar code scanner or some other AIDC technology. If a labeler choses a bar code form of AIDC, we expect that the bar code form of the UDI will be tested for print quality. We interpret Sec. Sec. 801.3 and 801.40 as specifying that a UDI is composed solely of a single DI and one or more of the five PIs listed in Sec. Sec. 801.3 and 801.40(b), along with the data delimiters for the DI and PIs. While some of the FDA-accredited issuing agencies may allow for non-UDI elements, such as quantity, in the UDI carrier, we do not recognize any such additional non-UDI elements as being part of the UDI. For the purposes of this draft guidance, ``data delimiter'' means a defined character or set of characters that identifies specific data elements within an encoded data string. The data delimiters indicate the DI value or the PI values that follow each data delimiter within the UDI, and may also indicate other non-UDI elements that may be included within the UDI carrier. Data delimiters for the DI and PIs should be included in the UDI. If non-UDI elements are included in the UDI carrier, separate data delimiters for any these non-UDI elements outside the scope of a UDI should be included in the UDI carrier. Data delimiters should be included in both the easily readable plain-text and AIDC technology forms of the UDI. The data delimiters vary based on the FDA- [[Page 48816]] accredited issuing agencies, and consist of a specific set of characters used to identify the information immediately following the data delimiter. For purposes of this draft guidance, we define ``UDI carrier'' as the means to convey the UDI and any non-UDI elements by using easily readable plain-text and AIDC forms. In the UDI carrier, the data represented in the UDI should precede any non-UDI elements and should be distinguishable from the UDI elements. The easily readable plain- text form of the UDI should be ordered to specify the DI first, followed by the PIs. If there are any non-UDI elements in the UDI carrier, the non-UDI elements should follow the PIs that are part of the UDI. For more information on non-UDI elements capable of being included in the UDI carrier, labelers should contact their FDA- accredited issuing agency. 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 ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)''. 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: Are there any additional standards, in addition to those referenced in this draft guidance, that should be used to determine the print quality of the AIDC form of the UDI? 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 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 ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)'' may send an email request to [email protected] or [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 GUD1500035 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: July 20, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17554 Filed 7-25-16; 8:45 am] BILLING CODE 4164-01-P
![48814 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Numbers of Average bur-
Numbers of Total annual Total capital
Activity responses per den per Total hours
respondents responses costs
respondent response
Submission of rotational plans for health
warning statements .............................. 100 1 100 60 6,000 $1,200
1 There are no operating and maintenance costs associated with this collection of information.
FDA estimates a total of 100 DEPARTMENT OF HEALTH AND comment will be made public, you are
respondents will respond to this HUMAN SERVICES solely responsible for ensuring that your
collection of information and take 60 comment does not include any
hours to complete a rotational warning Food and Drug Administration confidential information that you or a
plan for a total of 6,000 burden hours. [Docket No. FDA–2016–D–1853] third party may not wish to be posted,
In addition, capital costs are based on such as medical information, your or
100 respondents mailing in their Unique Device Identification System: anyone else’s Social Security number, or
submission at a postage rate of $12 for Form and Content of the Unique confidential business information, such
a 5-pound parcel (business parcel post Device Identifier; Draft Guidance for as a manufacturing process. Please note
mail delivered from the furthest Industry and Food and Drug that if you include your name, contact
delivery zone). Therefore, FDA Administration Staff; Availability and information, or other information that
estimates that the total postage cost for Request for Comments identifies you in the body of your
comments, that information will be
mailing the rotational warning plans to AGENCY: Food and Drug Administration, posted on http://www.regulations.gov.
FDA to be $1,200. HHS. • If you want to submit a comment
In the Federal Register of February, ACTION:Notice of availability; request with confidential information that you
19, 2016 (81 FR 8505), FDA published for comments. do not wish to be made available to the
a 60-day notice requesting public public, submit the comment as a
comment on the proposed collection of SUMMARY: The Food and Drug written/paper submission and in the
information. One comment was PRA Administration (FDA) is announcing the manner detailed (see ‘‘Written/Paper
availability of the draft guidance for Submissions’’ and ‘‘Instructions’’).
related comment was received.
industry and FDA staff entitled ‘‘Unique
(Comment) The comment believes Device Identification System: Form and Written/Paper Submissions
that warning plans should not be Content of the Unique Device Identifier Submit written/paper submissions as
renewed every year, but should remain (UDI).’’ When finalized, this draft follows:
in force as long as necessary after their document will define the expected • Mail/Hand delivery/Courier (for
approval content and forms of the unique device written/paper submissions): Division of
(Response) FDA does not require that identifier (UDI), to assist both labelers Dockets Management (HFA–305), Food
a previously FDA-approved warning and FDA-accredited issuing agencies and Drug Administration, 5630 Fishers
plan be resubmitted. FDA reviews and better ensure the UDIs developed under Lane, rm. 1061, Rockville, MD 20852.
approves warning plans only once, systems for the issuance of UDIs are in • For written/paper comments
unless a submitter seeks to change the compliance with the unique device submitted to the Division of Dockets
identification system rule (UDI Rule). Management, FDA will post your
distribution or display of warnings on
This draft guidance is not the final comment, as well as any attachments,
packages or rotation of warnings in
version of the guidance nor is it in effect except for information submitted,
advertisements, in which case the at this time.
submission would be considered a marked and identified, as confidential,
DATES: Although you can comment on if submitted as detailed in
supplement. The purpose of FDA’s
any guidance at any time (see 21 CFR ‘‘Instructions.’’
proposed extension is to account for the
10.115(g)(5)), to ensure that the Agency Instructions: All submissions received
entry of new smokeless tobacco product
considers your comment of this draft must include the Docket No. FDA–
brands and advertising onto the market guidance before it begins work on the 2016–D–1853 for ‘‘Unique Device
place. final version of the guidance, submit Identification System: Form and
Dated: July 20, 2016. either electronic or written comments Content of the Unique Device Identifier
Leslie Kux, on the draft guidance by September 26, (UDI).’’ Received comments will be
Associate Commissioner for Policy. 2016. placed in the docket and, except for
[FR Doc. 2016–17569 Filed 7–25–16; 8:45 am] ADDRESSES: You may submit comments those submitted as ‘‘Confidential
as follows: Submissions,’’ publicly viewable at
BILLING CODE 4164–01–P
http://www.regulations.gov or at the
Electronic Submissions Division of Dockets Management
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday
following way: through Friday.
srobinson on DSK5SPTVN1PROD with NOTICES
• Federal eRulemaking Portal: http:// • Confidential Submissions—To
www.regulations.gov. Follow the submit a comment with confidential
instructions for submitting comments. information that you do not wish to be
Comments submitted electronically, made publicly available, submit your
including attachments, to http:// comments only as a written/paper
www.regulations.gov will be posted to submission. You should submit two
the docket unchanged. Because your copies total. One copy will include the
VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM 26JYN1](https://thefederalregister.org/doc/81_FR_48957/page/1.svg)
![48816 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
accredited issuing agencies, and consist request to CDRH-Guidance@fda.hhs.gov ADDRESSES: You may submit comments
of a specific set of characters used to or ocod@fda.hhs.gov, or by calling 1– as follows:
identify the information immediately 800–835–4709 or 240–402–7800, to
Electronic Submissions
following the data delimiter. receive an electronic copy of the
For purposes of this draft guidance, document. Please use the document Submit electronic comments in the
we define ‘‘UDI carrier’’ as the means to number GUD1500035 to identify the following way:
convey the UDI and any non-UDI guidance you are requesting. • Federal eRulemaking Portal: http://
elements by using easily readable plain- www.regulations.gov. Follow the
text and AIDC forms. In the UDI carrier, V. Paperwork Reduction Act of 1995 instructions for submitting comments.
the data represented in the UDI should This draft guidance refers to Comments submitted electronically,
precede any non-UDI elements and previously approved collections of including attachments, to http://
should be distinguishable from the UDI information described in FDA www.regulations.gov will be posted to
elements. The easily readable plain-text regulations. These collections of the docket unchanged. Because your
form of the UDI should be ordered to information are subject to review by the comment will be made public, you are
specify the DI first, followed by the PIs. Office of Management and Budget solely responsible for ensuring that your
If there are any non-UDI elements in the (OMB) under the Paperwork Reduction comment does not include any
UDI carrier, the non-UDI elements Act of 1995 (44 U.S.C. 3501–3520). The confidential information that you or a
should follow the PIs that are part of the collections of information in 21 CFR third party may not wish to be posted,
UDI. For more information on non-UDI part 801 have been approved under such as medical information, your or
elements capable of being included in OMB control number 0910–0485, and anyone else’s Social Security number, or
the UDI carrier, labelers should contact the collections of information in 21 CFR confidential business information, such
their FDA-accredited issuing agency. part 830 have been approved under as a manufacturing process. Please note
OMB control number 0910–0720. that if you include your name, contact
II. Significance of Guidance
information, or other information that
This draft guidance is being issued Dated: July 20, 2016.
identifies you in the body of your
consistent with FDA’s good guidance Leslie Kux,
comments, that information will be
practices regulation (21 CFR 10.115). Associate Commissioner for Policy. posted on http://www.regulations.gov.
The draft guidance, when finalized, will [FR Doc. 2016–17554 Filed 7–25–16; 8:45 am] • If you want to submit a comment
represent the current thinking of FDA BILLING CODE 4164–01–P with confidential information that you
on ‘‘Unique Device Identification do not wish to be made available to the
System: Form and Content of the public, submit the comment as a
Unique Device Identifier (UDI)’’. It does DEPARTMENT OF HEALTH AND written/paper submission and in the
not establish any rights for any person HUMAN SERVICES manner detailed (see ‘‘Written/Paper
and is not binding on FDA or the public. Submissions’’ and ‘‘Instructions’’).
You can use an alternative approach if Food and Drug Administration
it satisfies the requirements of the Written/Paper Submissions
[Docket No. FDA–2013–N–0879]
applicable statutes and regulations. Submit written/paper submissions as
Agency Information Collection follows:
III. Request for Comments Activities; Proposed Collection; • Mail/Hand delivery/Courier (for
FDA is seeking additional information Comment Request; Procedures for the written/paper submissions): Division of
on this issue. FDA is particularly Safe and Sanitary Processing and Dockets Management (HFA–305), Food
interested in receiving information Importing of Fish and Fishery Products and Drug Administration, 5630 Fishers
relating to the following question: Are Lane, Rm. 1061, Rockville, MD 20852.
there any additional standards, in AGENCY: Food and Drug Administration, • For written/paper comments
addition to those referenced in this draft HHS. submitted to the Division of Dockets
guidance, that should be used to ACTION: Notice. Management, FDA will post your
determine the print quality of the AIDC comment, as well as any attachments,
form of the UDI? SUMMARY: The Food and Drug except for information submitted,
Administration (FDA or we) is marked and identified, as confidential,
IV. Electronic Access announcing an opportunity for public if submitted as detailed in
Persons interested in obtaining a copy comment on the proposed collection of ‘‘Instructions.’’
of the draft guidance may do so by certain information by the Agency. Instructions: All submissions received
downloading an electronic copy from Under the Paperwork Reduction Act of must include the Docket No. FDA–
the Internet. A search capability for all 1995 (the PRA), Federal Agencies are 2013–N–0879 for ‘‘Agency Information
Center for Devices and Radiological required to publish notice in the Collection Activities; Proposed
Health guidance documents is available Federal Register concerning each Collection; Comment Request;
at http://www.fda.gov/MedicalDevices/ proposed collection of information, Procedures for the Safe and Sanitary
DeviceRegulationandGuidance/ including each proposed extension of an Processing and Importing of Fish and
GuidanceDocuments/default.htm or at existing collection of information, and Fishery Products.’’ Received comments
http://www.fda.gov/ to allow 60 days for public comment in will be placed in the docket and, except
BiologicsBloodVaccines/ response to the notice. This notice for those submitted as ‘‘Confidential
GuidanceComplianceRegulatory invites comments on the information Submissions,’’ publicly viewable at
srobinson on DSK5SPTVN1PROD with NOTICES
Information/default.htm. Guidance collection provisions of our regulations http://www.regulations.gov or at the
documents are also available at http:// requiring reporting and recordkeeping Division of Dockets Management
www.regulations.gov. Persons unable to for processors and importers of fish and between 9 a.m. and 4 p.m., Monday
download an electronic copy of fishery products. through Friday.
‘‘Unique Device Identification System: DATES: Submit either electronic or • Confidential Submissions—To
Form and Content of the Unique Device written comments on the collection of submit a comment with confidential
Identifier (UDI)’’ may send an email information by September 26, 2016. information that you do not wish to be
VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM 26JYN1](https://thefederalregister.org/doc/81_FR_48957/page/3.svg)
Document Created: 2018-02-08 08:00:38
Document Modified: 2018-02-08 08:00:38
| 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; request for comments. | |
| 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 comment of 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 September 26, 2016. | |
| 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 protected] For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010. | |
| FR Citation | 81 FR 48814 |
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