[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Pages 51829-51830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20837]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0427]
Public Workshop on Medical Devices and Nanotechnology:
Manufacturing, Characterization, and Biocompatibility Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Medical Devices & Nanotechnology: Manufacturing,
Characterization, and Biocompatibility Considerations.'' The purpose of
this workshop is to obtain information on manufacturing,
characterization, and biocompatibility evaluation of medical devices
containing or utilizing nanomaterials and nanostructures, including
diagnostics. FDA is seeking input on these topics and requests comments
on a number of related questions.
Date and Time: The workshop will be held on September 23, 2010, 8
a.m. to 5 p.m. Persons interested in attending, must register by 5 p.m.
on September 15, 2010. Space availability permitting, on-site
registration will be available on a first come first serve basis. If
you would like your comments to be considered for workshop discussion,
please submit your comments by September 15, 2010. Please submit all
other comments by October 22, 2010.
Location: The public workshop will be held at the Hilton Washington
DC/North Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877. For
directions, please contact the hotel at 301-977-8900 or refer to their
Web page at: www.gaithersburg.hilton.com.
Contact Person: Daya Ranamukhaarachchi, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5574, Silver
Spring, MD 20993, 301-796-6155, FAX: 301-847-8510, email:
[email protected].
Registration and Requests for Oral Presentations: Interested
persons must register by September 15, 2010 at http://www.fda.gov/MedicalDevices/NewsEvents/WorskshopsConferences/default.htm (select the
appropriate meeting from the list). Registrants must provide the
following information: (1) Name, (2) title, (3) company or organization
(if applicable), (4) mailing address, (5) telephone number, (6) email
address, and (7) request to make an oral presentation or be a
participant in round-table discussions (if applicable). 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 7:30 a.m.
If you wish to make an oral presentation during any of the public
comment sessions at the workshop (see section II of this document), you
must indicate this at the time of registration. FDA requests that
presentations focus on the areas defined in section III of this notice.
You should also identify which discussion topic you wish to address in
your presentation. In order to keep each open session focused on the
discussion topic at hand, each oral presentation should address only
one discussion topic. FDA will do its best to accommodate requests to
speak. Registered participants may send written material for oral
presentations to the contact person by 5 p.m. on September 15, 2010.
If you would like to participate in the two planned round-table
discussions (see section II of this document), you must indicate this
interest at the time of registration, and also submit a brief statement
that describes your experience or expertise with nanotechnology. There
will be a limited number of round-table participants. FDA will attempt
to have a range of constituencies represented in this discussion group.
Others in attendance at the public workshop will have an opportunity to
listen to each round-table discussion and provide public comments, time
permitting.
If you need special accommodations due to a disability, please
contact Susan Monahan at 301-796-5661 or email:
[email protected] at least 7 days in advance of the public
workshop.
Comments: FDA is holding this public workshop to obtain information
on a number of specific questions regarding manufacturing and
characterization requirements and the biocompatibility evaluation for
medical devices utilizing nanotechnology. If you would like your
comments to be considered for workshop discussion, please submit your
comments by September 15, 2010. Please submit all other comments by
October 22, 2010.
Regardless of attendance at the public workshop, interested persons
may submit to the Division of Dockets Management either electronic or
written comments on this document. 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. In addition, when responding to specific
questions as outlined below, please identify the question you are
addressing. 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
Nanomaterials, measured in nanometers (a billionth of a meter),
often possess physical and chemical properties that are different from
their larger counterparts. Due to the high surface area to volume
ratio, the small size, and the type of nanoscale material, these
materials may exhibit altered magnetic, electrical, optical properties
and altered chemical and biological activities. These characteristics
provide the potential for nanomaterials to be used in a variety of
medical device applications. However, some of these nanomaterial
properties may also present safety concerns that are not found in their
larger counterparts. The use of nanotechnology is increasingly
applicable and provides novel opportunities in medical device
development. The scientific hurdles (e.g., biocompatibility and
toxicity) for safe use of nanomaterials in medical devices, including
the processes and standards for their manufacture and characterization,
are not understood.
In July 2007, FDA's Nanotechnology Task Force issued a report
describing the state of the science and regulatory challenges in
translating nanotechnology into FDA-regulated products (available at
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm). A general finding of
the report is that nanoscale materials
[[Page 51830]]
present regulatory challenges similar to those posed by products using
other emerging technologies and that these challenges may be magnified
because nanotechnology can be used in, or used to make, any FDA-
regulated product. In addition, the properties of a material with
features in the nanoscale range might change, impacting the safety and
effectiveness of the FDA-regulated products.
The objective of this public workshop is to obtain information on
manufacturing, characterization, and evaluation of biocompatibility of
medical devices containing or utilizing nanomaterials and
nanostructures.
II. Public Participation
There are two types of opportunities for participation planned for
the public workshop: Time limited oral presentations and round-table
discussions.
If you wish to make an oral presentation during the public
workshop, you must indicate this at the time of registration. The
number of presentations may be limited based on the number of requests
received during the public comment period. When registering, you will
be required to identify the title of the topic you wish to address in
your presentation and answer all the related questions on the
registration form at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. FDA will do its best to accommodate
requests to present and will focus discussion to the topics described
in this document (see section III of this document). Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for joint
presentations. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is to
begin.
To close each of the two sessions, FDA will hold a round-table
discussion between FDA staff and selected participants representing a
range of constituencies. If you wish to be a participant in round-table
discussions, you must indicate this interest at the time of
registration, and also submit a brief statement that describes your
experience or expertise with nanotechnology. FDA will attempt to have a
range of constituencies represented in this discussion group. Others in
attendance at the workshop will have an opportunity to listen during
each round-table discussion and provide public comments, time
permitting. FDA will determine the participants based on the requests
received. The participants in each round-table discussion will remark
on the presentations given during the session, engage in a dialogue
with each other and FDA staff, and provide closing thoughts on the
session. Round-table participants will not be asked to develop
consensus opinions during the discussion, but rather to provide their
individual perspectives.
III. Issues for Discussion
The workshop will focus on two topics: (1) Manufacturing and
characterization of medical devices containing or utilizing
nanomaterials or nanostructures; (2) biocompatibility evaluation of
medical devices containing or utilizing nanomaterials or
nanostructures. The discussion on manufacturing and characterization
will include the evaluation of physico-chemical properties of
nanomaterials or nanostructures, characterization methods required,
device manufacturing processes and evaluation of the final processed
device after sterilization, and stability and aging studies. The
discussion on biocompatibility evaluation will include testing for
potential release of nanomaterials and additional testing
considerations other than standard testing methods to determine the
biocompatibility and toxicity of devices containing or utilizing
nanomaterials or structures. For further information, please refer to
the meeting registration Web page at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
IV. Transcripts
Please be advised that as soon as a transcript is available, it can
be obtained in either hardcopy or on CD-ROM, after submission of a
Freedom of Information Act 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, approximately 15 working days after the public
workshop. A transcript of the public workshop will be available on the
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from
the list).
Dated: August 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20837 Filed 8-20-10; 8:45 am]
BILLING CODE 4160-01-S