Medical Devices
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
