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Public Workshop - Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act, March 7, 2012

Thu, 02/16/2012 - 5:32am
U.S. Food & Drug Administration

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act.” This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies.

The purpose of the workshop is to provide a forum for discussion among FDA, industry, governmental agencies, academia, clinicians and various stakeholders with experience in epidemiology, statistics, and biomedical research to advance the design and methodologies for medical device surveillance studies in the “postmarket” setting, i.e., after FDA premarket approval or clearance of the device and marketing of the device has begun.

This meeting will be held March 7, 2012, beginning at 8:00 am - 5:30 pm at the following location:

FDA White Oak Campus

10903 New Hampshire Avenue

Building 31 Conference Center (Great Room, Room 1503)

Silver Spring, MD 20993

This workshop will be webcast.

If you wish to attend this Workshop, you must register by close of business on February 29, 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.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 4321, Silver Spring, MD 20993, 301-796-5661, email: susan.monahan@fda.hhs.gov.

Attendance In-Person

Webcast

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For questions regarding workshop content please contact:

Samantha Jacobs

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Ave., Bldg. 66, rm. 4201C

Silver Spring, MD 20993

301-796-6897

e-mail: samantha.jacobs@fda.hhs.gov

or

Mary Beth Ritchey

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Ave., Bldg. 66, rm. 4118,

Silver Spring, MD 20993

301-796-6638

e-mail: maryelizabeth.ritchey@fda.hhs.gov

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