[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]


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

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.

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

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: 
Daya.Ranamukhaarachchi@fda.hhs.gov.
    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: 
susan.monahan@fda.hhs.gov 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