FDA Public Meeting on Pediatric Devices

A lot of recent focus by legislators and scientists is on health care and medical products specifically designed to meet the needs of the pediatric population.  As we know there are challenges to bringing medical products of children to the market, and there has been a paucity of device focused discussions/workshops about how to best study the safety and effectiveness of devices for pediatric disorders.

To address this challenge, FDA is planning to hold a public meeting to gather information related to collecting sound scientific information in clinical trials for pediatric devices. Six specialties of pediatric disorders: cardiology/pulmonology, musculoskeletal; genitourinary/renal; GI/abdominal; speech/audiology; and neurological will be discussed; including ways to improve and validate diagnostic testing for pediatric diseases.

Clinical/research experts from all specialties will lead the discussions about what data needs to be collected in pediatric device clinical trials.  The format of the meeting will include a general session in the morning of October 29th followed by breakout sessions each on one of the specific topics listed above.  The breakout sessions will be moderated by a panel of experts in each subspecialty area and will discuss questions related to collection of meaningful clinical data for devices intended for pediatric use.

Logistical info:
Date: October 29-30, 2009
Time: 8:00 am-5:30 pm (10/29) and 8 am to noon (10/30)
Location: Holiday Inn College Park located off of I-95 at 10000 Baltimore Ave, College Park, MD 20740.
For more information please check the website and watch for the Federal Register Posting.  Registration and discounted hotel information will be forthcoming shortly.

Learn more here.

Contact: Barbara Buch, MD, Deputy Director,  Division of Surgical, Orthopaedic and Restorative devices
U.S. Food and Drug Administration, Center for Devices and Radiological Heath
O (301) 796-5650
C (301) 796-6804
Fax: (301) 847-8117