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.
The meeting will be 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
| Date/Time | Agenda |
|---|---|
| February 12, 2009 8:00 - 9:00am |
Registration and Continental Breakfast |
| 9:00– 9:15 | Welcome and Introduction |
| 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 |
Advanced registration is necessary to attend or present at the meeting or participate in the vendor display. Seating is limited to 300 persons and if capacity is reached, registration will close.
You can register to attend the meeting online.
If you register as a presenter or to participate in the vendor display, you do not need to also register as an attendee.
Because of the format of the meeting, we will only have a short time for additional presentations (time permitting). We encourage attendees to raise their issues and concerns during the discussion portion of the 4 main topic areas. We also encourage persons and groups having similar interests to consolidate their information and present it through a single representative.
However, if you would like to register to provide presentation at the end of the day, please register online.
We will schedule each presentation and notify each participant by e-mail with the approximate time your presentation is scheduled to begin. The time allotted for presentations may be between 5 to 15 minutes, depending on the number of people who wish to present. Confirmed presenters need to send final electronic presentations in Microsoft PowerPoint, Microsoft Word, or PDF by 6 February 2009 to CDRHUDI@fda.hhs.gov.
We are providing an opportunity for meeting participants, including FDA staff, to learn about various technologies that can be used for UDI. There will be no fee for participating in the vendor display. For the purposes of this meeting, we are only interested in displays from vendors of automatic identification technologies that can be used to identify medical devices. At the time of registration, you will be asked to submit a short summary of your product. We can accommodate 10-15 vendors at this meeting. When vendor registration reaches this number, additional vendor display registrants will be placed on a wait-list. If you have been placed on the wait-list, we will notify you by e-mail if you become confirmed. There will be no onsite registration for vendors. Each vendor will be provided with a 6-foot tabletop space. Please note that Internet access will not be available. Because of time constraints, vendors may register either to present at the meeting or participate in the vendor display. You may not register for both.
You can register to participate in the vendor display online.
If you need special accommodations because of a disability, please contact Jay Crowley on 240-276-2389 or cdrhudi@fda.hhs.gov at least seven days before the conference.
We will also be providing real-time webcasting of the meeting. The link for the webcast will be posted to this site approximately one week prior to the meeting. Though you do not need to register for to use the webcast, we will send out information about the webcast to those who request it – please contact cdrhudi@fda.hhs.gov.
Webcast participants will also be able to submit questions and comments electronically.
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
Updated January 16, 2009
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