80 FR 36821 - Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments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 80, Issue 123 (June 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 123 (June 26, 2015)
| Page Range | 36821-36822 | |
| FR Document | 2015-15719 |
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)] [Notices] [Pages 36821-36822] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15719] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2245] Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' Direct marking is an important feature of FDA's unique device identification system. This document is intended to assist industry and FDA staff to understand FDA's requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of ``reprocessing'' for purposes of UDI direct marking requirements. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 24, 2015. ADDRESSES: An electronic copy of the draft guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Unique Device Identification: Direct Marking of Devices'' to the Office of the Center Director, Guidance and Policy Development, Center for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. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993- 0002, 301-796-5995, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 226 of the Food and Drug Administration Amendments Act of 2007 and section 614 of the Food and Drug Administration Safety and Innovation Act amended the Federal Food, Drug, and Cosmetic Act to add section 519(f) (21 U.S.C. 360i(f)), which directs FDA to issue regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices. The unique device identification system final rule was published on September 24, 2013 (78 FR 58786) (the UDI Rule). 21 CFR 801.45 requires a device bear a permanent UDI marking if the device is intended to be used more than once and intended to be reprocessed before each use. It details the UDI format when provided as a direct marking, and provides criteria for exceptions to this UDI direct marking requirement. As explained in the preamble of the UDI Rule, UDI direct marking requirements apply to devices that are intended to be used for months or years, sometimes many years. Because such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages. UDI direct marking helps to ensure the adequate identification of such devices through their distribution and use. However, the UDI Rule does not define ``intended to be used more than once'' and ``reprocessed.'' FDA's interpretation of these terms is included in this draft guidance, but FDA seeks additional information on its current definition of ``reprocessing'' for purposes of UDI direct marking requirements. FDA guidance entitled ``Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff'' issued on March 17, 2015 (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf) (the Reprocessing Guidance), indicates that reprocessing of reusable devices [[Page 36822]] generally encompasses three steps--point-of-use processing, thorough cleaning, and disinfection or sterilization. The Reprocessing Guidance makes clear, however, that certain devices may be suitably reprocessed after cleaning alone and may not require further disinfection or sterilization. It is important to note that the Reprocessing Guidance is intended, among other things, to provide guidance in crafting and validating reprocessing instructions to be included in the labeling of reusable devices generally, and it may not be applicable for determining whether a UDI direct marking should be required on a specific device intended to be reused. For purposes of UDI direct marking requirements, FDA considers a device that is intended to be cleaned and either sterilized or disinfected to be intended to be reprocessed. FDA has some concern about whether cleaning alone, without subsequent sterilization and/or disinfection, should fit within the definition of ``reprocessing'' for purposes of UDI direct marking requirements. Therefore, FDA is seeking additional information on this issue. FDA is particularly interested in receiving information relating to the following questions:FDA is concerned that devices intended to be used more than once tend to be separated from its original label during reprocessing, making accurate identification of devices difficult or impossible. Should the definition of ``reprocessing'' for purposes of UDI direct marking requirements include cleaning alone without subsequent disinfection and/or sterilization of the device? 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? This draft guidance, when finalized, is intended to assist industry, particularly labelers, as defined under 21 CFR 801.3, and FDA staff understand FDA's requirements for UDI direct marking of devices, and the criteria for exceptions. 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 represents the Agency's current thinking on ``Unique Device Identification: Direct Marking of Devices.'' It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. 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. Guidance documents are also available at http://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 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; 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; 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. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Dated: June 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-15719 Filed 6-25-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices 36821
• improve the standards-based DEPARTMENT OF HEALTH AND found in brackets in the heading of this
technology solution to encourage HUMAN SERVICES document.
widespread adoption. FOR FURTHER INFORMATION CONTACT: UDI
Food and Drug Administration Regulatory Policy Support, Center for
II. Questions to Stakeholders
[Docket No. FDA–2015–D–2245] Devices and Radiological Health, Food
1. What other potential benefits to and Drug Administration, 10903 New
stakeholders can be achieved through Unique Device Identification: Direct Hampshire Ave., Bldg. 66, Rm. 3303,
the use of a standards-based technology Marking of Devices; Draft Guidance for Silver Spring, MD 20993–0002, 301–
solution focusing on EHR and EDC Industry and Food and Drug 796–5995, email: GUDIDSupport@
integration? Administration Staff; Availability and fda.hhs.gov.
Request for Comments SUPPLEMENTARY INFORMATION:
2. What are the challenges to the
implementation of a standards-based AGENCY: Food and Drug Administration, I. Background
technology solution focusing on EHR HHS.
Section 226 of the Food and Drug
and EDC integration? ACTION: Notice. Administration Amendments Act of
3. What are the gaps between the data SUMMARY: The Food and Drug 2007 and section 614 of the Food and
collected in a healthcare setting by Administration (FDA) is announcing the Drug Administration Safety and
EHRs vs. clinical research data required availability of the draft guidance Innovation Act amended the Federal
for regulated drug development? entitled ‘‘Unique Device Identification: Food, Drug, and Cosmetic Act to add
4. Are there any perceived regulatory Direct Marking of Devices.’’ Direct section 519(f) (21 U.S.C. 360i(f)), which
marking is an important feature of directs FDA to issue regulations
obstacles to the implementation of a
FDA’s unique device identification establishing a unique device
standards-based technology solution
system. This document is intended to identification system for medical
focusing on EHR and EDC integration?
assist industry and FDA staff to devices along with implementation
(Examples include: Source data timeframes for certain medical devices.
verification, remote monitoring, 21 CFR understand FDA’s requirements for
direct marking of devices with a unique The unique device identification system
part 11, patient privacy, access control final rule was published on September
and confidentiality safeguards.) If yes, device identifier (UDI). In addition, FDA
is seeking information on what 24, 2013 (78 FR 58786) (the UDI Rule).
what approach(es) would you 21 CFR 801.45 requires a device bear
processes should be considered to meet
recommend to overcome these a permanent UDI marking if the device
the definition of ‘‘reprocessing’’ for
obstacles? is intended to be used more than once
purposes of UDI direct marking
5. Are there any obstacles to the requirements. and intended to be reprocessed before
implementation of a standards-based each use. It details the UDI format when
DATES: Although you can comment on provided as a direct marking, and
technology solution focusing on EHR
any guidance at any time (see 21 CFR provides criteria for exceptions to this
and EDC integration? 10.115(g)(5)), to ensure that the Agency UDI direct marking requirement. As
6. What standards-based solutions considers your comments on this draft explained in the preamble of the UDI
may exist? guidance before it begins work on the Rule, UDI direct marking requirements
final version of the guidance, submit apply to devices that are intended to be
III. Requests for Response
either electronic or written comments used for months or years, sometimes
Comments, proposed approaches, on the draft guidance by September 24, many years. Because such devices are
interest to participate, and responses to 2015. intended to be reprocessed and reused,
the questions are to be identified with ADDRESSES: An electronic copy of the they will inevitably be separated from
the docket number found in brackets in draft guidance document is available for their original labels and device
the heading of this document. Interested download from the Internet. See the packages. UDI direct marking helps to
parties should include the following SUPPLEMENTARY INFORMATION section for ensure the adequate identification of
information in the request: Contact information on electronic access to the such devices through their distribution
name, contact phone number, email draft guidance. Submit written requests and use. However, the UDI Rule does
address, name of the stakeholder, and for a single hard copy of the draft not define ‘‘intended to be used more
address. Once requests for participation guidance document entitled ‘‘Unique than once’’ and ‘‘reprocessed.’’ FDA’s
are received, FDA will contact Device Identification: Direct Marking of interpretation of these terms is included
Devices’’ to the Office of the Center in this draft guidance, but FDA seeks
interested stakeholders to discuss
Director, Guidance and Policy additional information on its current
demonstration projects. The elapsed
Development, Center for Devices and definition of ‘‘reprocessing’’ for
time duration of any project is expected Radiological Health, Food and Drug purposes of UDI direct marking
to be approximately 12 months but may Administration, 10903 New Hampshire requirements.
be extended as needed. Ave., Bldg. 66, Rm. 5431, Silver Spring, FDA guidance entitled ‘‘Reprocessing
Dated: June 22, 2015. MD 20993–0002. Send one self- Medical Devices in Health Care Settings:
Leslie Kux, addressed adhesive label to assist that Validation Methods and Labeling;
Associate Commissioner for Policy. office in processing your request. Guidance for Industry and Food and
Submit electronic comments on the Drug Administration Staff’’ issued on
[FR Doc. 2015–15644 Filed 6–25–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
draft guidance to http:// March 17, 2015 (available at http://
BILLING CODE 4164–01–P
www.regulations.gov. Submit written www.fda.gov/downloads/
comments to the Division of Dockets MedicalDevices/
Management (HFA–305), Food and Drug DeviceRegulationandGuidance/
Administration, 5630 Fishers Lane, Rm. GuidanceDocuments/UCM253010.pdf)
1061, Rockville, MD 20852. Identify (the Reprocessing Guidance), indicates
comments with the docket number that reprocessing of reusable devices
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![36822 Federal Register / Vol. 80, No. 123 / Friday, June 26, 2015 / Notices
generally encompasses three steps— An alternative approach may be used if Dated: June 22, 2015.
point-of-use processing, thorough such approach satisfies the Leslie Kux,
cleaning, and disinfection or requirements of the applicable statute Associate Commissioner for Policy.
sterilization. The Reprocessing and regulations. [FR Doc. 2015–15719 Filed 6–25–15; 8:45 am]
Guidance makes clear, however, that BILLING CODE 4164–01–P
certain devices may be suitably III. Electronic Access
reprocessed after cleaning alone and Persons interested in obtaining a copy
may not require further disinfection or of the draft guidance may do so by DEPARTMENT OF HEALTH AND
sterilization. It is important to note that downloading an electronic copy from HUMAN SERVICES
the Reprocessing Guidance is intended, the Internet. A search capability for all
among other things, to provide guidance Food and Drug Administration
Center for Devices and Radiological
in crafting and validating reprocessing [Docket No. FDA–2015–N–1837]
Health guidance documents is available
instructions to be included in the
at http://www.fda.gov/MedicalDevices/
labeling of reusable devices generally, Agency Information Collection
DeviceRegulationandGuidance/
and it may not be applicable for Activities; Proposed Collection;
determining whether a UDI direct GuidanceDocuments/default.htm.
Guidance documents are also available Comment Request; Electronic User
marking should be required on a Fee Payment Request Forms
specific device intended to be reused. at http://www.regulations.gov. Persons
For purposes of UDI direct marking unable to download an electronic copy AGENCY: Food and Drug Administration,
requirements, FDA considers a device of ‘‘Unique Device Identification: Direct HHS.
that is intended to be cleaned and either Marking of Devices’’ may send an email ACTION: Notice.
sterilized or disinfected to be intended request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the SUMMARY: The Food and Drug
to be reprocessed. FDA has some
document. Please use the document Administration (FDA) is announcing an
concern about whether cleaning alone,
without subsequent sterilization and/or number 1400031 to identify the opportunity for public comment on the
disinfection, should fit within the guidance you are requesting. proposed collection of certain
definition of ‘‘reprocessing’’ for information by the Agency. Under the
IV. Paperwork Reduction Act of 1995 Paperwork Reduction Act of 1995 (the
purposes of UDI direct marking
requirements. Therefore, FDA is seeking PRA), Federal Agencies are required to
This draft guidance refers to
additional information on this issue. publish notice in the Federal Register
previously approved collections of
FDA is particularly interested in concerning each proposed collection of
information described in FDA
receiving information relating to the information and to allow 60 days for
regulations. These collections of
following questions: public comment in response to the
information are subject to review by the
• FDA is concerned that devices notice. This notice solicits comments on
Office of Management and Budget
intended to be used more than once Electronic User Fee Payment Request
(OMB) under the Paperwork Reduction
tend to be separated from its original Forms.
Act of 1995 (44 U.S.C. 3501–3520). The
label during reprocessing, making collections of information in 21 CFR DATES: Submit either electronic or
accurate identification of devices part 801 have been approved under written comments on the collection of
difficult or impossible. Should the OMB control number 0910–0485; the information by August 25, 2015.
definition of ‘‘reprocessing’’ for collections of information in 21 CFR ADDRESSES: Submit electronic
purposes of UDI direct marking part 807, subpart E, have been approved comments on the collection of
requirements include cleaning alone under OMB control number 0910–0120; information to http://
without subsequent disinfection and/or the collections of information in 21 CFR www.regulations.gov. Submit written
sterilization of the device? part 814, subparts A through E, have comments on the collection of
• What public health benefits would been approved under OMB control information to the Division of Dockets
be served by requiring a UDI direct number 0910–0231; and the collections Management (HFA–305), Food and Drug
marking to be affixed to devices of information in 21 CFR part 830 Administration, 5630 Fishers Lane, Rm.
intended to be reused for which pertaining to GUDID labeler accounts 1061, Rockville, MD 20852. All
reprocessing instructions include and data submissions addressed in this comments should be identified with the
cleaning only and not disinfection and/ draft guidance document have been docket number found in brackets in the
or sterilization? approved under OMB control number heading of this document.
This draft guidance, when finalized,
0910–0720. FOR FURTHER INFORMATION CONTACT: FDA
is intended to assist industry,
PRA Staff, Office of Operations, Food
particularly labelers, as defined under V. Comments and Drug Administration, 8455
21 CFR 801.3, and FDA staff understand
Interested persons may submit either Colesville Rd., COLE–14526, Silver
FDA’s requirements for UDI direct
electronic comments regarding this Spring, MD 20993–0002, PRAStaff@
marking of devices, and the criteria for
document to http://www.regulations.gov fda.hhs.gov.
exceptions.
or written comments to the Division of SUPPLEMENTARY INFORMATION: Under the
II. Significance of Guidance Dockets Management (see ADDRESSES). It PRA (44 U.S.C. 3501–3520), Federal
This draft guidance is being issued is only necessary to send one set of Agencies must obtain approval from the
consistent with FDA’s good guidance comments. Identify comments with the Office of Management and Budget
tkelley on DSK3SPTVN1PROD with NOTICES
practices regulation (21 CFR 10.115). docket number found in brackets in the (OMB) for each collection of
The draft guidance represents the heading of this document. Received information they conduct or sponsor.
Agency’s current thinking on ‘‘Unique comments may be seen in the Division ‘‘Collection of information’’ is defined
Device Identification: Direct Marking of of Dockets Management between 9 a.m. in 44 U.S.C. 3502(3) and 5 CFR
Devices.’’ It does not create or confer and 4 p.m., Monday through Friday, and 1320.3(c) and includes Agency requests
any rights for or on any person and does will be posted to the docket at http:// or requirements that members of the
not operate to bind FDA or the public. www.regulations.gov. public submit reports, keep records, or
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Document Created: 2015-12-15 14:14:53
Document Modified: 2015-12-15 14:14:53
| 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. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 24, 2015. | |
| Contact | UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993- 0002, 301-796-5995, email: [email protected] | |
| FR Citation | 80 FR 36821 |
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