2011-10273. Study Methodologies for Diagnostics in the Postmarket Setting; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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: [e-mail]; 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: [e-mail].

Registration: In-person and Web-cast registration and information are available at the following Web site: http://www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​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 [e-mail] 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.