2001D-0281 Proposed Globally Harmonized Alternative for PMA Procedures
FDA Comment Number : EC2
Submitter : Mr. Stephen Dolle Date & Time: 12/09/2005 03:12:07
Organization : Dolle Communications
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I SUPPORT a more uniform global system of evalation of medical drugs and devices. I make this COMMENT both as a patient-consumer, and as a health professional, the latter spanning some 25 years in the U.S. I have seen many changes over the years, sometimes burdensome, and at other times too late in coming. I have suffered personal harm on several occassions for reasons, in part, 1) one that the FDA could have prevented through more responsive and expedient approval of a 'EU-foreign' medical device, and 2) one that the U.S. mfr failed to report as a design problem, and to which FDA oversight was wholely inadequate and allowed harm to come to thousands of U.S. citizens.

A second issue I must bring up in this discussion is that of lack of requisite FDA and NIH cooperation with U.S. citizens/comsumers who are also researchers, such as myself, and who also may operate a small business or consulting company within the health care field. I draw attention to both FDA and NIH barriers enacted against regulatory and sciences advocacy from these private citizens and the small businesses they may operate or be starting. FDA and NIH too often only allow shared cooperation with 'non-profit' organizations and practicing physicians and university scientists. Your objections have long been that you cannot further the efforts of an individual or small business, but I must assert here, that many of these non-profit organizations, physicians, and university scientists today are more akin to 'for-profit,' because they often receive vastly more funds than their counterpart small business researchers, they take in sizable funds from large corporate sources, and activities often have a bias and/or conflict. If FDA and NIH want to secure the best new available scientific and policy information, you would more the wiser to better cooperate with private citizen researchers and small business. These are great additional sources of global scientific information, of critical importance to the FDA.

In support of my above comments, I want to share my own science and policy information which I host on my web site for patients, field professionals, industry, and FDA, which is of critical value to all concerned. There are no non-profit organizations or government agencies that host such extensive content in support of hydrocephalus, CNS shunts and assessment, artifical intelligence assistive technologies, and alternative neuro-therapies research.

I have authored a small study on neurological disorders and the role of the hippocampus - which I believe to be vastly overlooked in research and brain imaging. I have authored a new study on CNS shunt malfunction and a new assessment protocol. I openly pose questions and suggestions for CNS shunt mfrs, and the protocol is of great importance for selecting and re-programming of CNS shunts, post discharge monitoring, and assessment of hydrocephalus. My information, research, and papers can be found at: 'SEE INTERNET LINKS BELOW'

(My own) Dolle Communications Web Site
1. Main Hydrocephalus Section www.diaceph.com/hydrocephalus.htm
2. New CNS Shunt Selection/Assessment www.diaceph.com/ShuntSelectionModel.htm
3. Hippocampus Study www.diaceph.com/NeuroCompensStudy.htm
4. Assistive Technology Research www.diaceph.com/AITechnology.htm
5. Music & Art Therapy Research www.diaceph.com/MusicandArtTherapy.htm
6. Regulatory Affairs Recomm www.diaceph.com/RegulatoryAffairsandLaw.htm