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 : EC13
Submitter : Mr. Mark Isaac Date & Time: 08/25/2004 04:08:11
Organization : Elizabeth Glaser Pediatric AIDS Foundation
International Organization
Category :
Issue Areas/Comments
On behalf of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), I am pleased to respond to the Food and Drug Administration?s (FDA) request for comments on the barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children. We believe this request for comments, which will assist the FDA in preparing a Congressionally mandated report on pediatric device availability, is an important step in ensuring that children have the same right to safe and effective medical devices that we enjoy as adults.
Please see attached document.