Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue - Update
MedSun: Newsletter #69, February 2012

Workshops and Conferences

The December 2011 MedSun Newsletter provided information about The Food and Drug Administration's (FDA) public workshop entitled: "Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue." The purpose of the public workshop was to receive public comment on the use of scientific research data, including published scientific literature, to extrapolate effectiveness claims from adults to children and between pediatric subpopulations in order to support and establish pediatric indications for medical devices. To view the newly available workshop transcript please see the link below.

Additional Information:

Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue - Update. January 5, 2012.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278053.htm

MedSun Newsletter. Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue. December 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=67#1


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