Public Workshop – Medical Devices and Nanotechnology: Manufacturing – Sep 23rd

Public Workshop – Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations, September 23, 2010

The purpose of this workshop is to obtain information on the safety and effectiveness of medical devices utilizing nanotechnology. Specifically, FDA would like public input 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, Time and Location
• Federal Register Notice
• Questions for Discussion
• Agenda
• Registration
• Contact Us

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Date, Time and Location

This workshop will be held on September 23, 2010, 8 am to 5 pm.

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

The meeting will be webcast.

Agenda

Public Workshop on Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations – Draft Agenda

Date:  September 23

Venue: Hilton Washington DC/North Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD, 20877

7:30	Registration
8:00	Welcome/Structure of the Day and Logistics
8:10	Opening remarks
Session I: Manufacturing/characterization of medical devices containing or utilizing nanomaterials or nanostructures
8:20	Moderator’s introduction of Session I - CDRH’s list of scientific/regulatory considerations for discussion – [Questions for Discussion]
8:30	Manufacturing/characterization and Quality Control (QC) considerations for medical devices containing or utilizing nanomaterials or nanostructures Expert speaker presentation(s)
9:00	Industry/Public comments
10:00	Break
10:15	Session I Roundtable discussion
12:15	Lunch
Session II:Biocompatibility/bio-distribution evaluation for medical devices containing or utilizing nanomaterials or nanostructures
1:15	Moderator’s introduction of Session II - CDRH’s list of scientific/regulatory considerations for discussion – [Questions for Discussion]
1:25	Biocompatibility/Toxicity considerations for medical devices containing or utilizing nanomaterials or nanostructures Expert speaker presentation(s)
2:00	Industry/public comments
3:00	Break
3:15	Session II Roundtable discussion
4:45	Concluding remarks
5:00	Adjourn

Registration to Attend the Workshop

Interested persons must register by September 15, 2010.

There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on 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 the Supplementary Information in FR notice), you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in section III of the Supplementary Information in FR 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 the Supplementary Information in FR notice), 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, at susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.

Title Mr. Mrs. Ms. None First Name * Last Name * M.D. Ph.D. Email* Please enter Email again for verification : Phone Number* (No dashes or spaces in phone numbers please) Company or Organization * Attendance * I will be attending: In Person Via Webcast (A link to the webcast will be sent to registrants in a separate email.) Request to Speak If you would like to speak, please select a session: Not Speaking Session I Session II Round Table If you would like to participate in a round table discussion, please select a session: No Round Table Session I Session II If participating in a round table discussion, please list any experience with nanotechnology:

Contact Us

Daya Ranamukhaarachchi
Office of the Center Director, CDRH
10903 New Hampshire Avenue
WO-66, Room 5574
Silver Spring, MD 20993
(301) 796-6155
(301) 847-8512 – Fax
Daya.ranamukhaarachchi@fda.hhs.gov