2005N-0426 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
FDA Comment Number : EC1
Submitter : Mr. Stephen Dolle Date & Time: 12/09/2005 03:12:13
Organization : Dolle Communications
Category : Individual Consumer
Issue Areas/Comments
Invite and consider more consumer comments. Improve FDA and NIH science policy communications with non-university researchers, patient advocates, and small businesses that serve FDA regulated industries.

I spent 6 to 12 months authoring a critical Petition to the FDA in 1996 (96N-0444) on CNS Anti-Siphon Shunts, widespread under-reporting, and product labeling inadequacies with these devices. I undertook this as an affected patient user, a consumer, and I was NOT paid and fees for my important contributions. My efforts led to your 1999 STAMP Conference on CNS Shunt Technology, and also to my inventing an all new type of CNS shunt monitoring system, the DiaCeph Test. I had suspected "misconduct" by FDA staff and industry, and further, the all new technology I invented was NOT permitted in the New Technology Discussion of STAMP.

The STAMP Committee was also to institute a number of new initiatives, including, 1st time device literature for user patients. That was Jan. 1999, and as of Dec. 2005, few or none of these initiatives have been instituted. As to my statement of FDA mis-conduct, that was confirmed by your Criminal Devision in 2001.

I would highly suggest that if the FDA wants private citizens, private researchers, and advocates to further the agency's efforts, that we be treated with the same dignity, consideration, and respect to which we have afforded you.

I would also suggest you see my regulatory affairs, hydrocephalus, CNS shunt, and neuroscience research on my web site at: www.diaceph.com
You need to institute and integrate a new Internet reporting system of consumer comments provided to medical manufacturers, with a specific section on your FDA web site. Some manufacturers currently permit consumer comments and suggestions are their company web site. This needs to be more widely available, and then integrate with correlating FDA records.