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U.S. Department of Health and Human Services

Medical Devices

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

The purpose of this workshop was 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

This workshop was held on September 23, 2010, 8 am to 5 pm at the Hilton Washington DC/North Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877. The meeting was also 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

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