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Public Workshop - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle, September 12-13, 2012

Thu, 08/30/2012 - 12:00am
U.S. Food & Drug Administration

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Leveraging Registries with Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle.” The topic to be discussed is best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal.

Date, Time and Location

This workshop will be held September 12, 2012, from 8:00 a.m. to 5:00 p.m. and September 13, 2012, from 8:00 a.m. to 5:00 p.m., at the following location:

Greenbelt Marriott
6400 Ivy Lane
Greenbelt, MD 20770
301-614-8202

The workshop will be available by Webcast.

Registration to Attend the Workshop

If you wish to attend this workshop in person, you must register online by September 10, 2012. If you wish to view this workshop by Webcast, you must register online by September 5, 2012.

There is no fee to register for the workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

FDA is holding this public workshop to obtain information on best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the workshop topics. The deadline for submitting comments related to this public workshop is October 10, 2012.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Cindy Garris, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO-66 Room 4321, Silver Spring, MD 20993, 301-796-5861, FAX: 301-847-8142, email: cynthia.garris@fda.hhs.gov, no later than September 5, 2012.

Attendance In-Person (closes Sep. 10)
Webcast (closes Sep. 5)
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Contact Us

For questions regarding workshop content please contact:

Anna Ghambaryan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO-66 Room 4107
Silver Spring, MD 20993
301-796-6030
email: anna.ghambaryan@fda.hhs.gov

Or

Danica Marinac-Dabic
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO-66 Room 4110
Silver Spring, MD 20993
301-796-6689
email: Danica.Marina-Dabic@fda.hhs.gov

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