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Federal Register: Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations

Mon, 08/23/2010 - 5:32am
U.S. Food & Drug Administration

[Federal Register: August 23, 2010 (Volume 75, Number 162)]

[Notices]

[Page 51829-51830]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr23au10-87]

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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:

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

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