Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop, 43691-43693 [2011-18369]
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Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Notices
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:
Sharon Lappalainen, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1238, Silver Spring,
MD 20993–0002, 301–796–6322.
SUPPLEMENTARY INFORMATION:
I. Background
The guidance describes a means by
which electrocardiograph electrodes
may comply with the requirement of
special controls for class II devices. In
the Federal Register of October 4, 2007
(72 FR 56771), and Docket No. FDA–
2007D–0309, FDA proposed to classify
electrocardiograph electrodes, intended
to acquire and transmit the electrical
signal at the body surface to a processor
that produces an electrocardiogram
(ECG) or vectorcardiogram, into class II.
FDA also proposed to exempt this
device from premarket notification
requirements and issued a draft
guidance document to describe the
special control requirements. FDA
invited interested persons to comment
on the proposed regulation and the draft
guidance document by January 8, 2008.
FDA received seven comments on the
proposed rule. These comments
addressed issues pertaining to labeling,
the scope of the devices subject to the
classification rule, and testing. In
response, FDA has revised the labeling
section of the guidance, has clarified the
scope of the guidance, and has clarified
the information regarding testing for
shelf life. Elsewhere in this issue of the
Federal Register, FDA is publishing a
final rule to classify electrocardiograph
electrodes into class II (special controls)
and to exempt the device from 510(k)
premarket notification procedures.
wreier-aviles on DSKDVH8Z91PROD with NOTICES
II. Significance of Special Controls
Guidance Document
FDA believes that adherence to the
recommendations described in this
guidance document, in addition to the
general controls, will provide
reasonable assurance of the safety and
effectiveness of electrocardiograph
electrodes classified under § 870.2360
(21 CFR 870.2360). In order to be
classified as a class II device under
§ 870.2360, an electrocardiograph
electrode must comply with the
requirements of special controls;
manufacturers must address the issues
requiring special controls as identified
in the guidance document, either by
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following the recommendations in the
guidance document or by some other
means that provides equivalent
assurances of safety and effectiveness.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Electronic Access
[Docket No. FDA–2011–N–0495]
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov.
To receive ‘‘Class II Special Controls
Guidance Document: Electrocardiograph
Electrodes,’’ you may either send an email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a paper copy.
Please use the document number
(#1597) to identify the guidance you are
requesting.
Unique Device Identification for
Postmarket Surveillance and
Enforcement; Public Workshop
IV. Paperwork Reduction Act
This guidance refers to previously
approved collections of information
found 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 807 subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; and the collections
of information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. 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.
Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–18390 Filed 7–20–11; 8:45 am]
BILLING CODE 4160–01–P
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Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
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
https://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
SUMMARY:
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Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Notices
wreier-aviles on DSKDVH8Z91PROD with NOTICES
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 https://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 https://
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 https://
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 https://www.fda.gov/UDI
for more information about UDI.
FDA is also leading an effort to
develop and implement a national
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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. Healthrelated 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 healthrelated activities including:
• Reducing medical errors,
• Reporting and assessing devicerelated 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 https://
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
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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 healthrelated 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.
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Federal Register / Vol. 76, No. 140 / Thursday, July 21, 2011 / Notices
E. The Role of UDI in Postmarket
Surveillance and Compliance
17. How we can use UDIs in healthrelated 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.
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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 https://
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 https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm257194.htm (or go to https://
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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0477]
Standard Operating Procedure for
‘‘Notice to Industry’’ Letters
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of the standard operating
procedure (SOP) for ‘‘Notice to
Industry’’ Letters. The SOP describes
the Center for Devices and Radiological
Health’s (CDRH) process to clarify and
more quickly inform stakeholders when
CDRH has changed its expectations
relating to, or otherwise has new
scientific information that could affect,
data submitted as part of an
Investigational Device Exemption (IDE)
or premarket submission that needs to
be disseminated in a timely manner.
DATES: The Agency encourages
interested parties to submit information
and either electronic or written
comments by September 19, 2011.
ADDRESSES: Submit electronic
comments or information to https://
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.
FOR FURTHER INFORMATION CONTACT:
Angela Krueger, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring,
MD 20993, 301–796–6380, e-mail:
angela.krueger@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
The Task Force on the Utilization of
Science in Regulatory Decision Making
(the Task Force) published a
Preliminary Report and
Recommendations in August 2010. In
the report, the Task Force noted that
when new scientific information
changes CDRH’s regulatory thinking, it
has been challenging for the Center to
communicate the change and its basis to
all affected parties in a meaningful and
timely manner. The Task Force
recommended that the Center make use
of more rapid tools for broad
communication on regulatory matters,
including establishing a standard
practice for sending ‘‘Notice to
Industry’’ Letters to all manufacturers of
a particular group of devices for which
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43693
the Center has changed its expectations
for data submitted as part of an IDE or
premarket application on the basis of
new scientific information.
Currently, manufacturers typically
learn of changes CDRH implements at
the time of or soon after a decision is
made through individual engagement
with the Center, often not until after
they have prepared a premarket
submission. Reviewers may implement
these changes, such as requesting new
clinical data or using a new test method,
on a case by case basis, with immediate
supervisory concurrence when it is
necessary to protect the public health.
For example, a reviewer may request
that sponsors test their implantable
device for durability because new data
demonstrates that this type of device is
prone to failure due to premature wear
and tear of the technology. Although
CDRH may issue a detailed guidance
document, the document may not be
published until a year or more after a
branch- or division-level decision has
been made to request the information
because of the resource constraints in
developing guidance documents.
Therefore, CDRH believes that timely
communication with industry about
changes in regulatory expectations or
new scientific information is important.
The Task Force recommended that
CDRH use ‘‘Notice to Industry’’ Letters
in these circumstances, although not
required, and adopt a uniform template
and terminology for such letters,
including clear and consistent language
to indicate that the Center has changed
its regulatory expectations, the general
nature of the change, and the rationale
for the change. The Task Force
contemplated that CDRH could
potentially issue ‘‘Notice to Industry’’
Letters, if such letters constitute
guidance, as ‘‘Level 1—Immediately in
Effect’’ guidance documents under 21
CFR 10.115(g)(2), and would open a
public docket upon their issuance
through a notice of availability in the
Federal Register.
This SOP was developed to address
this recommendation from the Task
Force. Where appropriate, CDRH will
communicate new expectations as
‘‘Notice to Industry’’ Guidance Letters,
which will comply with Good Guidance
Practices, or CDRH will communicate
other new scientific information as
‘‘Notice to Industry’’ Advisory Letters.
The Center will post both types of
‘‘Notice to Industry’’ Letters on its Web
site, and will also use additional
methods for distributing the Letters to
identified stakeholders. When CDRH
issues a ‘‘Notice to Industry’’ Guidance
Letter concerning a change in premarket
expectations that will affect pending
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]]>Agencies
[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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm257194.htm (or go to https://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
