Document ID: FDA-2011-N-0002-0042
Agency: fda
Document Type: Notice
Title: Study Methodologies for Diagnostics in the Postmarket Setting; Public Workshops
Posted Date: 2011-04-28T04:00Z

[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23825-23826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10273]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Study Methodologies for Diagnostics in the Postmarket Setting; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Study Methodologies for Diagnostics in the 
Postmarket Setting.'' The purpose of the public workshop is to provide 
a forum for discussion among FDA, governmental Agencies, academia, 
physicians, and various stakeholders with expertise in epidemiology, 
statistics, diagnostics, and biomedical research to advance the 
methodologies for diagnostics in the postmarket setting.
    Date and Time: The public workshop will be held on May 12, 2011, 
from 8:30 a.m. to 5:15 p.m. Participants are encouraged to arrive early 
to ensure time for parking and security screening before the workshop. 
Sign-in will be required.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    The public workshop with also be available to be viewed via online 
Web-cast (see Registration).
    Contact Person: Hui-Lee Wong, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 4611, Silver Spring, MD 20993-0002, 301-796-6234, e-mail: hui-lee.wong@fda.hhs.gov; or Xueying Sharon Liang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4110, Silver Spring, MD 20993-0002, 301-796-9601, 
e-mail: XueyingSharon.Liang@fda.hhs.gov.
    Registration: In-person and Web-cast registration and information 
are available at the following Web site: http://www.fda.gov/
MedicalDevices/NewsEvents/WorkshopsConferences/

[[Page 23826]]

ucm251696.htm. There is no fee to attend the public workshop, but 
attendees must register in advance. Registration will be on a first-
come, first-served basis. Non-U.S. citizens are subject to additional 
security screening, and they should register as soon as possible. 
Registration ends May 5, 2011.
    If you need special accommodations because of a disability, please 
contact Susan Monahan at susan.monahan@fda.hhs.gov at least 7 days in 
advance of the public workshop.

SUPPLEMENTARY INFORMATION:

I. Why are we holding this public workshop?

    The purpose of the public workshop is to facilitate discussion 
among FDA, governmental Agencies, academia, physicians, and the key 
stakeholders in the scientific community on issues related to the 
studies and methodological approaches examining diagnostics in the 
postmarket settings. We aim to create a dialogue between professionals 
with epidemiologic, statistical, and clinically relevant expertise in 
diagnostic devices to determine the evidence gaps and questions, 
datasets and approaches for conducting postmarket surveillance and 
robust analytic studies to improve our understanding of the performance 
of diagnostics at the postmarket settings.

II. Who is the target audience for this public workshop? Who should 
attend this public workshop?

    This public workshop is open to all interested parties. The target 
audience is professionals in the scientific community with experience 
in epidemiology, diagnostics, or biomedical research with an interest 
in diagnostic devices and epidemiologic study methodology.

III. What are the topics we intend to address at the public workshop?

    We intend to discuss a large number of methodological concerns at 
the workshop, including, but not limited to the following:
     Gaps and challenges in postmarket studies of diagnostics,
     Identifying and verifying emerging data sources and 
methodologies, and
     Fostering interdisciplinary collaboration towards 
identifying new opportunities in methodologies for diagnostic devices.

IV. Where can I find out more about this public workshop?

    Background information on the public workshop, registration 
information, the agenda, information about lodging, transcripts, and 
other relevant information will be posted, as it becomes available, on 
the Internet at http://www.fda.gov/cdrh/meetings.html.

    Dated: April 22, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-10273 Filed 4-27-11; 8:45 am]
BILLING CODE 4160-01-P