2004N-0254 - Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments
FDA Comment Number : EC10
Submitter : Dr. Stuart Goldstein Date & Time: 08/25/2004 04:08:33
Organization : FDA
Federal Government
Category :
Issue Areas/Comments
I am a pediatric nephrologist who serves as a special government employee and member of the CDRH advisory panel. I want to first thank you for your interest in children.

I forwarded the 3 questions posed in your request for comments to the medical and surgical division chiefs at Texas Children's Hospital, which is the largest pediatric hospital in the United States. While the specific device needs were obviously peculiar to each specialty, a number of themes emerged. I have distilled these for each question, and attached a copy of their individual responses for your review.


Stuart L. Goldstein