Medical Devices
FDA Unique Device Identification Public Workshop: February 12, 2009
- Federal Register Notice
- Date, Time and Location
- Agenda
- Transcripts and Presentations
- Videos
- Contacts
Federal Register Notice
FDA has published a notice in the Federal Register announcing a Public Workshop on 12 February 2009 and requesting comments on a number of UDI related issues.
Please see Docket No. FDA-2008-N-0661, CDRH 200866. Unique Device Identification System; Public Workshop; Request for Comments (also available in PDF form).
Comments due February 27, 2009.
(NOTE: The registration link in the Federal Register notice is incorrect. Registration details are available here.)
Date, Time and Location
The meeting was held on 12 February 2009 from 9:00 a.m. to 5:00 p.m. at the following location:
Marriott Gaithersburg Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD, 20878
(301) 590-0044
www.marriott.com/hotels/travel/waswg-gaithersburg-marriott-washingtonian-center
Agenda
| Date/Time | Agenda |
|---|---|
| February 12, 2009 8:00 - 9:00am |
Registration and Continental Breakfast |
| 9:00– 9:15 | Welcome and Introduction Jay Crowley |
| 9:15 – 10:30 | The Unique Device Identifier (standards, production identifier, small packages) |
| 10:30 – 10:45 | BREAK |
| 10:45-12:00 | Placement and Technology (kits, standards (1D and 2D), direct part marking, RFID) |
| 12:00 – 1:00 | LUNCH |
| 1:00 – 2:15 | The Unique Device Identifier Database (elements/attributes, development, use) |
| 2:15– 2:30 | BREAK |
| 2:30 – 3:45 | Implementation and Adoption (by stakeholders, e.g., distributors, hospitals, payors) |
| 3:45– 4:45 | Other presentations (time permitting) |
| 4:45 – 5:00 | Wrap-up and close |
Transcripts and Presentations
Jay Crowley - Welcome and Introduction (PDF)
- Panel 1 - The Unique Device Identifier (standards, production identifier)
- Panel 2 - Placement and Technology (small packages, kits, direct part marking)
- Transcript of Panel 2
- Rick Naples - Placement and Technology
- Werthwine - AdvaMed / Unique Device Identification
- Corwin Hee - General Commentary
- Mike Bernard, Kettering Health Network [no presentation]
- Panel 3 - The Unique Device Identifier Database (elements/attributes, development, use)
- Transcript of Panel 3
- Dennis Black - The Unique Device Identifier Database
- Jackie Elkin - Unique Device Identification System
- Kathleen Garvin - The Unique Device Identifier Database
- MJ Wylie - UDI Database
- David McCombs, Bon Secours Health System [no presentation]
- Panel 4 - Implementation and Adoption (by stakeholders, e.g., distributors, hospitals, payors)
- Transcript of Panel 4
- Joe Pleasant - Implementation and Adoption
- Gene Kirster - Data Standards Implementation and Adoption
- Steve Phurrough, CMS [no presentation]
- Napoleon Monroe - Unique Device Identifiers Implementation - Alternative Perspectives
- Greg Stivers, McKesson Corporation [no presentation]
- Individual Presentations
Videos
All videos are in Windows Media format and may be large (100+ megabytes).
- Video of Panel 1
- Video of Panel 2
- Video of Panel 3
- Video of Panel 4
- Video of Individual Presentations
Contacts
The workshop organizer may be contacted at:
Jay Crowley
Center for Devices and Radiological Health
U.S. Food and Drug Administration
1350 Piccard Drive, HFZ-500
Rockville, Maryland 20850
240-276-2389
e-mail: jay.crowley@fda.hhs.gov