Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue
MedSun: Newsletter #67, December 2011

Workshops and Conferences

The Food and Drug Administration is announcing a public workshop entitled: Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue.

The purpose of the workshop is 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. The workshop format will include small group breakout sessions to encourage the exchange of ideas between participants, so we're looking to have broad representation from outside the FDA.

FDA seeks representation from the pediatric medical device industry, consumers, and health care providers.

Additional Information:

Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims, December 5, 2011
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278053.htm.


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