[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Notices]
[Page 2601-2605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-112]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0661]
Unique Device Identification System; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Unique Device Identification System.'' The purpose
of the public workshop is to obtain information to help us better
understand the issues involved in the establishment of a unique device
identification system (UDI system) and request comments on this topic.
Dates and Time: The public workshop will be held on, February 12,
2009, from 9 a.m. to 5 p.m. See section V of this document for
additional dates associated with registration and participation in the
workshop.
Location: The public workshop will be held at the Marriott
Gaithersburg Washingtonian Center, 9751 Washingtonian Blvd.,
Gaithersburg, MD 20878, 301-590-0044.
Contact Person: Jay Crowley, Food and Drug Administration, Center
for Devices and Radiological Health (HFZ-500), 1350 Piccard Dr.,
Rockville, MD 20852, 240-276-2389, or Stephen Ripley, Food and Drug
Administration, Center for Biologics Evaluation and Research (HFM-17),
1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-6210.
Registration: Register electronically at http://www.fda.gov/cdrh/
ocd/udi/index.htmlby January 30, 2009. There is no registration fee for
the public workshop. Early registration is recommended because seating
is limited. Registration on the day of the public workshop will be
provided on a space available basis beginning at 8 a.m.
If you need special accommodations due to a disability, please
contact Jay Crowley (see Contact Person) by January 30, 2009.
Comments: Regardless of attendance at the public workshop,
interested persons may submit written or electronic comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The deadline for submitting comments regarding this
public workshop is February 27, 2009. 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
A. What Does Section 226 of the Food and Drug Administration Amendments
Act of 2007 (FDAAA) Require?
On September 27, 2007, President George W. Bush signed into law
FDAAA (Public Law 110-85). Section 226 of FDAAA amended the Federal
Food, Drug, and Cosmetic Act (the act) by requiring the establishment
of a UDI system. Specifically, section 226(a) of FDAAA created a new
section 519(f) of the act (21 U.S.C. 360i(f)) stating that ``The
Secretary shall promulgate regulations establishing a unique device
identification system for medical devices requiring the label of
devices to bear a unique identifier, unless the Secretary requires an
alternative placement or provides an exception for a particular device
or type of device. The unique identifier shall adequately identify the
device through distribution and use, and may include information on the
lot or serial number.''
A UDI system may provide for early detection of the warning signs
of a defective device and facilitate device recalls (Ref. 1) and other
possible benefits of a UDI system have been suggested.
B. Why Are We Holding a Public Workshop?
The enactment of section 519(f) of the act has raised many
questions for our consideration. For example, the statute requires the
UDI to go on the device's label, but it also allows for ``alternative
placement'' and for exceptions. Thus,
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what circumstances would justify alternative placement of the UDI, and
which devices should receive an exception from a UDI requirement?
Consequently, we are issuing this notice to announce that we will hold
a public workshop to discuss and to invite comment on the questions set
out in section II. B of this document.
II. Issues to Be Considered
A. Organization and Basic Instructions
We invite comments on the questions presented in this section. We
intend to discuss these same questions at the public workshop. If you
wish to comment in writing on a particular question, please identify
the question that you are addressing before providing your response to
the question. For example, your comment could take the following
format:
``Question 1--[Quote the question].''
``Response--[Insert your response].''
You do not have to address each question. Additionally, for those
questions pertaining to economic issues or the prevalence of a
particular problem or action, please provide data and/or references so
that we may understand the basis for your comment, figures, and any
assumptions that you used.
As this workshop will only take place over the course of a single
day, in order to most effectively use this time and obtain as much
information from as many diffferent points of view as possible, the
public workshop will be divided into sessions that focus on each of the
main topic areas. Each session will begin with an invited presentation
to describe the issue. This will be followed by a moderated question
and comment session. Following this discussion, the moderator will open
up the discussion to questions and comments on the topic from the
audience. Though limited, at the end of the day there will be time for
other presentations.
Because of the workshop's format, we will only have a short time
for additional presentations. We encourage attendees to raise their
issues and concerns during the discussion portion of the main topic
areas. We also encourage persons and groups having similar interests to
consolidate their information and present it through a single
representative.
Additionally, through this public workshop, we hope to gain greater
understanding of various automatic identification technologies.
Therefore, we invite manufacturers and organizations that market or
have in development automatic identification technologies, which could
be used with medical devices, to display these technologies. Questions
about whether your product or technology would fall within the scope of
this vendor display should be directed to the contact persons listed at
the beginning of this notice.
You may register to present at the public workshop or participate
in the vendor display at http://www.fda.gov/cdrh/ocd/udi/index.html.
Because of time constraints, vendors may register either to present at
the public workshop or participate in the vendor display. You may not
register for both. If you choose to participate in the vendor display,
you will have the opportunity to share information about your products
with FDA and other attendees when they visit your display.
B. Questions Pertaining to the UDI System
1. Which types of devices or particular devices should be subject to
the requirements of a UDI system? Which types of devices or particular
devices should be excepted?
Section 519(f) of the act states that the Secretary of Health and
Human Services may provide ``an exception for a particular device or
type of device.'' However, the statute does not specify any criteria
for an exception, nor does it describe the scope of an exception.
a. Should all devices be subject to the requirements of a UDI
system? Please explain your reasoning.
b. Are there types of devices or particular devices that should
receive an exception from the requirements of a UDI system? If so, what
types of devices or particular devices should receive an exception and
why?
2. What are the characteristics or aspects necessary to uniquely
identify a device?
Section 519(f) of the act states that the UDI ``shall adequately
identify the device through distribution and use, and may include
information on the lot or serial number.'' The statutory language does
not describe the characteristics or features that make a device
``unique'' or that ``adequately identify the device through
distribution and use.''
a. What characteristics are needed to uniquely identify a device?
b. What core attributes, elements, or characteristics of a device
should constitute a minimum data set for a device identifier?
c. What changes to an attribute, element, or characteristic
associated with the unique identification of a device change should
result in a new UDI?
d. Should the UDI include a component that represents package size
or packaging level?
e. To what extent would or should the list of unique device
characteristics vary depending on the type of device?
3. What should be the UDI's components?
a. Could existing standards, such as the standards used by GS1,
Health Industry Business Communications Council (HIBCC), or others be
used as a model for the UDI system? What are the advantages and
disadvantages of these existing organizations and standards?
b. Some identification systems currently in use employ a
combination of a device identifier (meaning information that identifies
the manufacturer, make, and/or model of the device) and a production
identifier (meaning information that relates to the lot or serial
number). What should the device ``identifier'' component of the UDI
cover or contain?
c. With respect to the production identifier, we note that the
statute says that the UDI may include information on the device's lot
or serial number. When should lot or serial number information be
required for a device? Are there particular devices for which serial
numbers should be required? If yes, what particular devices should be
labeled with a serial number? Please explain your reasoning.
d. How might we ensure that UDIs, regardless of the manufacturers
or devices associated with those UDIs, are uniform or standardized in
their structure or composition? For example, the NDC (National Drug
Code) number is always 10 digits long and always presents the labeler
code first, followed by the product code and then the package code.
Should we limit the number of ways that the UDI can be created or the
standards to be used?
e. How should the UDI be created to ensure that UDIs are unique?
4. Where should the UDI be placed? What should be the criteria for
alternative placement of the UDI?
The statute requires the label of devices to bear a unique
identifier, unless we require an ``alternative placement'' or provide
an exception. Section 201(k) of the act defines ``label'' ``as a
display of written, printed, or graphic matter upon the immediate
container of any article; and a requirement made by or under authority
of this act that any word, statement, or other information appear on
the label shall not be considered to be complied with unless such word,
statement, or other information also appears on the
[[Page 2603]]
outside container or wrapper, if any there be, of the retail package of
such article, or is easily legible through the outside container or
wrapper.''
a. Should we specify where on the label the UDI must appear? If so,
where should the UDI appear on the label? Please explain your
reasoning.
i. Should we allow the components of the UDI to be placed
separately on the same package or on different levels of packaging? For
example, if the UDI consists of a device identifier component and a
production identifier component, should we allow the device identifier
component of the UDI to be placed in one location and allow the
production identifier component to be placed elsewhere on the label or
on the device? Please explain your reasoning.
As another example, some devices are packaged individually and then
packaged again in a larger container (such as a ``shelf pack''). We are
aware that some manufacturers would prefer placing both the device
identifier component of the UDI and the production identifier component
of the UDI on the larger container and placing only the device
identifier component of the UDI on the individual packages. Separating
UDI components or allowing part (rather than all) of the UDI on package
labels may provide for flexibility in product labeling, but also
generate confusion as to which UDI to read or scan (if the UDI
components are separated) or limit the usefulness of the UDI if a
component of the UDI is not present.
ii. For barcodes (whether linear or two-dimensional (2D)), should
we require the UDI to be expressed in a concatenated manner (whereby
the components of the UDI are expressed on the same line adjacent to
each other) or in a stacked manner (whereby one component of the UDI
rests atop the other component)?
b. Are there devices where we should require the UDI to appear on
the device itself (direct part marking)? For example, it might be
beneficial to put the UDI on the device itself if the device is re-
processed because this might help firms identify or record how many
times a particular device has been reprocessed. Similarly, certain
single use devices (SUDs) sometimes are reprocessed, so a UDI on the
device itself could facilitate the mandatory and voluntary MedWatch
reporting relating to such reprocessed devices or facilitate other
activities (such as documenting sterilization reprocessing of SUDs and
validation studies) associated with SUDs. Conversely, are there devices
where the UDI cannot or should not go on the device itself? If so,
please describe those devices and explain why the UDI cannot or should
not go on the device.
c. If we allow for ``alternative placement'' of the UDI for some
particular devices or types of devices, what should be the general
criteria for requiring ``alternative placement'' of the UDI, e.g., such
as on the device itself or other location that is not on the label?
d. What specific challenges or limitations exist regarding
``alternative placement?'' For example, placing a UDI in an automatic
identification form on an implantable device may present issues as to
whether the automatic identification technology affects the device's
integrity or function. As another example, certain devices, such as
software, may pose particular challenges for how to label with a UDI.
5. How should the UDI be presented?
We are aware of several automatic identification technologies in
use, such as linear bar codes, 2D bar codes, and radio frequency
identification. We also note that various FDA regulations and
initiatives have required or recommended one or more automatic
identification technologies (see 21 CFR 201.25 (bar code label
requirement for human drug products); 21 CFR 610.67 (bar code label
requirement for biological products); Ref. 2; and section 505D of the
act (21 U.S.C. 355e) (regarding ``pharmaceutical security'' and
specifying ``promising technologies'' such as RFID (radio-frequency
identification), nanotechnology, encryption technologies, and other
``track-and-trace or authentication technologies'') ). Therefore:
a. Should we require human-readable UDIs or automatic
identification of UDIs or both? Are there devices where it would be
sufficient to have human-readable UDIs alone? Please explain your
reasoning. For example, devices used in a home care setting might not
need an automatic identification UDI because the home might not be
equipped to read the automatic identifier. Are there situations where
we should require both human-readable and automatic identification
UDIs? Please explain your reasoning.
b. Should we specify a particular type of automatic identification
technology or should we allow the automatic identification technology
to vary depending on the type of device? Should we identify automatic
identification standards (as opposed to specific technologies) that can
be used? Please explain your reasoning. Specifying a particular type of
automatic identification technology would enable hospitals and other
parties who might read or use a UDI to make specific investments in
scanning or reading equipment, but the technology chosen might not be
easily applied to all devices (if we require the UDI to be placed
somewhere other than the label.) For this question, we are particularly
interested in hearing from parties who might use UDIs as well as
entities that may have already adopted or installed device
identification systems.
c. Should we allow the use of different automatic identification
technologies to express different parts of the UDI? For example, the
device identifier component might be expressed in a linear bar code and
the production identifier component might be expressed in a 2D bar
code. Allowing the use of different technologies for different
components of the UDI may enable manufacturers to make more efficient
use of label space or space on the device itself, but it also could
generate confusion as to which identifier to read or scan and could
necessitate the purchase of several types of reading and scanning
equipment.
d. Are there existing standards or systems we should consider in
establishing the requirements for how the UDI must be presented? For
example, we are aware of various standards organizations, such as GS1
and the HIBCC, that exist and have specific formats or specifications
for automatic identifiers for products. Should we allow any or all of
these standards to be used?
6. How should the UDI Database be developed and maintained?
For parties to benefit from UDI information, it would seem
necessary for those parties to know, at a minimum, the UDIs that exist,
the specific device associated with each UDI, and the information
associated with each UDI. It might be efficient for one entity to
collect the UDIs, associate those UDIs with specific devices, and make
the information associated with those UDIs publicly available. However,
it is also conceivable (but perhaps less efficient or more costly) that
the information could rest with individual manufacturers themselves
(rather than FDA) or with a third party or third parties. Consequently:
a. How and when should we require UDIs and associated information
to be entered into a database? How frequently should we require changes
to a UDI or to the information associated with or linked to a UDI to be
reported?
b. Aside from information that is necessary to uniquely identify a
device,
[[Page 2604]]
what other information (if any) should be part of a UDI system database
or otherwise linked to the UDIs?
c. If variable data (such as a lot or serial number) is necessary
to uniquely identify a device, should such data be included in a UDI
system database?
C. Questions Pertaining to Possible Impacts of a UDI System
Many production situations that might be affected by UDI
requirements are complex. In its basic form, a device identifier is a
series of digits and/or letters associated with a specific device. At a
minimum, a system can be thought of as the set of procedures that allow
stakeholders to use an identifier. Through public consultation,
however, FDA has found that there are many different views as to the
purpose of a UDI system and different opinions about how to describe
and implement a UDI system. Because of the diversity of affected
devices and manufacturing processes, we expect that affected entities
might comply with UDI requirements in a variety of ways. If you respond
to the following questions about the costs and benefits of a UDI
system, we encourage you to provide as much detail and context as
possible. For example, if you identify exceptional costs related to
incorporating a UDI in certain production lines, we need to understand
the production process details. In addition, we specifically invite
small businesses to provide information about a UDI's potential impact.
1. What is the magnitude of the problem to be addressed by the
establishment of a UDI system?
Please describe and provide qualitative or quantitative evidence of
the incidence of deaths, injuries and illnesses associated with medical
devices. What role would a UDI system play in helping to reduce the
incidence of such deaths, injuries, and illnesses and how might the
structure of a UDI system facilitate this role?
2. Questions for manufacturers
a. Current practices. Describe your current practices for applying
standards to medical devices, marking identifiers on medical device
labeling and managing medical device identifier data. For example, how
do you currently use classification standards such as UNSPSC (United
Nations Standard Products Service Code), nomenclature standards such as
GMDN (Global Medical Device Nomenclature), and identification standards
such as GS1 or HIBCC? What percent of your devices are not currently
marked with a standardized identifier? Please describe any plans you
have to change these practices in the near future.
b. Changing current identifiers. If you were to add a UDI or change
the presentation of your current identifier, please describe your
approximate expected capital and operating costs (including labor) to
plan for, implement, and apply a UDI to product labeling. To provide
context for your estimate, please explain your expected approach to
adding a UDI, considering the possibility that a UDI might be a static
number (e.g., a manufacturer/product code) or that it might include a
variable number (e.g., manufacturer/product/lot code).
c. Encoding variable data. If you were to add a UDI bar code with
variable data (such as lot or serial number) to medical device
labeling, please describe how you would print the variable bar coded
information. For example, do you foresee using on-line label printing,
other in-house printing, or contract printers to add a UDI bar code?
d. Production line impacts. Considering your operations, are there
products where adding a UDI (human readable or barcode; static or
variable) to labeling would not be feasible without major capital
investment or overhauling production lines? If so, please describe the
products and suggest alternatives or solutions.
e. Small devices and small packages. A UDI could present a
challenge for some small packages. What percentage of your product line
consists of devices whose small size could make placing a UDI on a
label problematic? Of those devices identified, what ``alternative
placement'' of the UDI would be feasible? Please explain your
reasoning. Please describe the nature of the problems and costs to
solve such problems. Please suggest alternatives or solutions.
3. Questions for hospitals, nursing homes, and clinics
a. Using a UDI. If UDIs were placed on at least some medical
devices, what functions could a UDI serve in your institution?
b. Expenses. What expenses do you foresee in attempting to capture
and use UDIs placed on medical devices? If you foresee using UDIs, how
would you modify operations in your facility?
c. Adverse event reporting and recalls. How would capturing the UDI
change your recall management or adverse event reporting? For recalls
or adverse events involving the most serious device malfunctions or
failures, how have problems in device identification impaired your
recall management or adverse event reporting? Please describe the
magnitude of the problems you have encountered.
III. References
The following references have been placed on display in the
Division of Dockets Management (see Comments) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. 153 Cong. Rec. H10597 (daily ed., September 19, 2007)
(statement of Rep. Hooley).
2. FDA, ``FDA Counterfeit Drug Task Force Report: 2006 Update,''
p. 12, (http://www.fda.gov/oc/initiatives/counterfeit/report6_
06.pdf) (advocating use of RFID).
IV. Where and When Will the Public Workshop Occur?
We will hold the public workshop on February 12, 2009, from 9 a.m.
to 5 p.m., at the Marriott Gaithersburg Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD 20878.
V. Do You Have To Register To Attend a Public Workshop or To Make a
Presentation?
If you wish to make a presentation at or to attend the public
workshop, please register online at http://www.fda.gov/cdrh/ocd/udi/
index.html by January 30, 2009. The online registration form will
instruct you as to the information you should provide. Space may be
limited, and we will close on-site registration when the maximum
seating capacity is reached.
We will try to accommodate all persons who wish to make a
presentation. The time allotted for presentations will depend on the
number of people who wish to speak on a given topic, and the public
workshop schedule. Similarly, the time allotted to each topic may vary
depending on the expressed interests of persons registering for the
public workshop. To obtain updates on the public workshop, please visit
http://www.fda.gov/cdrh/ocd/udi/index.html. Additionally, regardless of
whether you wish to make a presentation or simply attend the public
workshop, if you need any special accommodations (such as wheelchair
access or a sign language interpreter), please notify Jay Crowley (see
Contact Person) by January 30, 2009.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be
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accepted by FDA only through FDMS at http://www.regulations.gov.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/cdrh/ocd/udi.index.html.
Dated: January 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-784 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-01-S