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 : EC2
Submitter : Dr. Paul M. Gammell Date & Time: 07/21/2004 11:07:30
Organization : Gammell Applied Technologies
Private Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
I do not have experience that is specialized in pediatric devices, although I have worked in ultrasound and was a reviewer in the Radiological Devices Branch of what was then DRAERD.



I do have a suggestion that may help in the long run. In an earlier job with the Navy I was the Contracting Officer?s Technical Representative (COTR) for several Small Business Innovative Research (SBIR) proposals. In possible collaboration with one of the National Institutes of Health (NIH) SBIR funding could be provided in this area. It has been my experience that when the COTR provides useful suggestions and orientation (but not attempting to actually direct the project) the end result is more relevant to society and profitable to the company. I know it is a delicate balance, but a completely ?hands off? approach can be a complete waste of money. The COTR must be interested in seeing the project through. In phase 2 of the SBIR the COTR should help the company learn of the regulatory considerations. The company should be encouraged to discuss their regulatory plans with the FDA at an early point in order to conserve valuable resources.