
[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43691-43693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18369]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0495]


Unique Device Identification for Postmarket Surveillance and 
Enforcement; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop on the adoption, implementation, and use of unique device 
identifiers (UDIs) in various health-related electronic data systems. 
The purpose of this workshop is to engage multiple stakeholders to 
obtain information and comments on issues confronting the effective and 
efficient incorporation of UDIs into appropriate data sets, to identify 
barriers and incentives to their adoption and use, and to understand 
the best solutions and practices to resolve open issues.
    Dates and Times: The public workshop will be held on September 12, 
2011, from 1 to 5 p.m. and on September 13, 2011, from 9 a.m. to 5 p.m. 
Submit electronic and written comments by October 13, 2011.
    Location: The public workshop will be held at the Bethesda North 
Marriott Hotel and Conference Center, 5701 Marinelli Road, Bethesda, MD 
20852; 301-822-9200.
    Contact Person: Jay Crowley, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20903, 301-980-1936, e-mail: 
jay.crowley@fda.hhs.gov
    Registration: Registration is free and will be on a first-come, 
first-served basis. To register for the public workshop--whether 
attending in person or for the Web cast--please visit http://www.fda.gov/UDI (or go the FDA Medical Devices News & Events--Workshops 
& Conferences calendar and select this public workshop from the posted 
events list). Please provide complete contact information for each 
attendee, including name, title, affiliation, address, e-mail, and 
telephone number. For those without Internet access, please contact Jay 
Crowley (see Contact Person) to register. Registration requests should 
be received by 5 p.m. on September 5, 2011. Early registration is 
recommended because seating is limited and, therefore, FDA may limit 
the number of participants from each organization. If time and space 
permit, onsite registration on the

[[Page 43692]]

day of the public workshop will be provided beginning at 11 a.m.
    Hotel reservations can be made by calling the hotel and requesting 
the group rate for the ``FDA UDI Public Workshop'' room block.
    If you need special accommodations due to a disability, please 
contact Jay Crowley (jay.crowley@fda.hhs.gov) at least 7 days in 
advance.
    The meeting will also be Web cast. Persons interested in 
participating by Web cast must register online by 5 p.m. on September 
5, 2011. Web cast participants will be sent connection requirements. 
More information on the Web cast can be found on our Web site at http://www.fda.gov/UDI.
    By August 12, 2011, and then as available, FDA will post the 
workshop agenda and discussion topics, registration information, 
information about lodging, and other relevant information on the 
Internet at http://www.fda.gov/UDI.
    Comments: Regardless of attendance at the public workshop, 
interested persons may submit either electronic or written comments by 
October 13, 2011. Submit electronic comments 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. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
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.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 226 of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) directs FDA to issue regulations establishing a UDI system 
for medical devices. FDA is developing proposed regulations to 
establish this UDI system to strengthen and improve FDA's enforcement 
of other statutory authorities and improve the identification of 
devices through distribution and use. This workshop will not address 
the FDA's UDI regulatory framework. However, UDI systems have been 
under development for some years by the U.S. and global device industry 
and some device manufacturers have been incorporating UDI into their 
product labeling and packaging. See http://www.fda.gov/UDI for more 
information about UDI.
    FDA is also leading an effort to develop and implement a national 
strategy for the best public health use of health-related electronic 
data related to devices that incorporates UDIs, including registries, 
and leverages existing processes and systems. Health-related data (from 
large data sources such as health insurers and integrated health 
systems, and others) contains a wealth of public health information 
that could be harnessed to contribute to understanding device safety 
and effectiveness. Currently, however, these data generally cannot be 
used to identify specific device exposures in patients. This is not the 
case for drug exposure, where the regular documentation of NDC numbers 
allows for robust analysis of pharmaceutical safety and effectiveness. 
Absent such information for devices, a vast amount of potentially 
useful data regarding patient safety and outcomes remains untapped.
    The incorporation of UDI into various health-related databases will 
greatly facilitate many important public health-related activities 
including:
     Reducing medical errors,
     Reporting and assessing device-related adverse events and 
product problems,
     Tracking of recalls,
     Assessing patient-centered outcomes and the risk/benefit 
profile of medical devices in large segments of the U.S. population,
     Providing an easily accessible source of device 
identification information to patients and health care professionals.
    The incorporation of UDI into various health-related databases 
would also greatly expand Sentinel Initiative capabilities to conduct 
active device surveillance given that Sentinel device data sources are 
currently limited to a few registries capturing short-term patient 
outcomes. FDA's Sentinel Initiative, on the Internet at http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm, seeks to 
establish ``a national electronic system that will transform FDA's 
ability to track the safety of drugs, biologics, medical devices--and 
ultimately all FDA-regulated products once they reach the market'' and 
``aims to develop and implement a proactive system that will complement 
existing systems that the Agency has in place to track reports of 
adverse events linked to the use of its regulated products.'' (Please 
note that this workshop will NOT address FDA's oversight of EHRs.)

II. Topics for Discussion at the Public Workshop

    This public workshop is intended to engage multiple stakeholders to 
inform FDA's efforts to promote and facilitate incorporation of UDIs 
into healthcare systems, obtain actionable information on the issues 
surrounding effective and efficient incorporation of UDIs into health-
related electronic records, and understand best solutions and 
practices. To that end, we will focus on the following issues:

A. Documenting Device Use Using UDIs in Electronic Health Records

    1. The current state of documentation of device use in health-
related databases, including EHRs.
    2. The barriers to, and various possible incentives for, the 
development, implementation and use of UDI in EHR systems.
    3. The possible roles and activities of various government 
stakeholders (including FDA, CMS, ONC, and NLM) necessary to drive the 
adoption and use of UDIs in EHRs and other health-related databases.
    4. Any other issues or concerns that would affect the efficient and 
effective incorporation of UDIs in EHRs and other health-related data.

B. The Role of UDI in Device Registries

    5. The current state of documentation of device use in registries.
    6. The future vision for device registries using UDI.
    7. How EHRs and other, similar population-based databases can be 
used to provide registries or registry-like data.
    8. Any technical issues confronting the effective and efficient 
incorporation of UDIs into appropriate data sets.

C. UDI's Role in National and Local Data Standards

    9. The current state of Health IT data standards in EHRs.
    10. The future vision for use of standards in EHRs to improve data 
quality and data exchange.
    11. The activities of the Health IT Standards Panel and its 
relationship to Meaningful Use.
    12. The relationship of data standards to UDI integration in 
hospital systems.

D. Integrating UDI Throughout Hospital Systems

    13. The particular issues associated with networked devices that 
need to be considered.
    14. The issues and challenges with device interoperability.
    15. The current and future state of MMIS and RTLS systems to 
support safe device use.
    16. How other information systems are adopting and implementing UDI 
and how these systems are integrating with other clinical information 
systems to transmit the appropriate data.

[[Page 43693]]

E. The Role of UDI in Postmarket Surveillance and Compliance

    17. How we can use UDIs in health-related electronic data systems 
to improve post-approval studies.
    18. How the documentation of UDIs can be used to improve the 
conduct of recalls.
    19. The issues associated with the use of UDI in claims data 
sources.
    20. How adverse event reporting can be improved.
    21. Other postmarket surveillance and enforcement activities that 
can be improved through the documentation of UDIs in these databases.

F. UDIs in Personal Health Records

    22. The device information currently being transmitted from the EHR 
to a patient's PHR.
    23. Any lessons learned that can be applied from documenting 
medication use.
    24. How the documentation of UDI in patients' PHRs can be used for 
postmarket surveillance, enforcement activities and to improve device 
use.
    25. Any differences in documentation and tracking of device use 
needed for different care settings (e.g., hospital, outpatient clinic, 
and home) and different device types (e.g., implants, home/patient use) 
that need to be considered.

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857. A link to the transcripts will 
also be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm257194.htm (or go to http://www.fda.gov and select this public workshop from the posted events 
list), approximately 45 days after the public workshop.

    Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18369 Filed 7-20-11; 8:45 am]
BILLING CODE 4160-01-P


