2004S-0233 - Solicitation of Comments on Stimulating Innovation in Medical Technologies
FDA Comment Number : EC5
Submitter : Mr. David Lovett Date & Time: 08/09/2004 06:08:18
Organization : American Academy of Orthopaedic Surgeons
Health Care Association
Category :
Issue Areas/Comments
Questions
1. What strategies and approaches could HHS implement to accelerate the development and application of new medical technologies?
The American Academy of Orthopaedic Surgeons (AAOS/Academy), representing over 19,000 Board certified orthopaedic surgeons, welcomes the opportunity to comment on the Food and Drug Administration?s (FDA) Critical Path Initiative [Docket No. 2004-N-0181]. While the Academy appreciates the efforts of FDA personnel in ensuring that drugs, medical devices, biological, and combination products are safe and effective, orthopaedic patients are adversely affected when new technologies are unavailable due to a lack of applied science or excessive regulatory burdens. The Academy has serious concerns about the lack of innovative orthopaedic medical products introduced into the United States marketplace and the deleterious effects it is having on patient care.

Attached are the Academy's comments on this issue.