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 : EC3
Submitter : Mr. Richard Podell Date & Time: 07/26/2004 04:07:53
Organization : Management Advisory Services
Device Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
Small size of pediatric device market would require economic incentive to device developers, such as orphan drug incentives.

Reluctance to expose younger patients to clinical trial risks requires even more stringent guidelines for IDE and more comprehensive education for parent/guardian, including issues relating to informed consent.