Still waiting for my report to show up in FDA online db (now searchable at www.fdable.com
). So, mailing and then emailing my report and pix in, it took about a month and several phone calls to get my report to the point where I rec'd written confirmation of receipt and a case # from the FDA. I'm hoping that folks who filed online had a quicker and easier process!
I haven't gotten around to finishing up my general complaint (about false advertising, dangerousness, Sciton's refusal to accept a patient complaint, request for investigation and enforcement). Been busy at work, and I am compiling a BUNCH of exhibits for that letter. This is the address I was given by the FDA Ombudsman on where to send that complaint: OCMedicalDeviceCo@fda.hhs.gov
The Ombudsman who responded to my query on Sciton's refusal to accept my complaint was:
David S. Buckles, PhD, FACC
10903 New Hampshire Avenue, WO32-4282
Silver Spring, MD 20993
He did offer to file a complaint w/ Office of Compliance on my behalf, but I declined and said I'd just submit the complaint myself to the email address he gave me. I did email him back asking if he was the Ombudsman for industry or for patients, or both, and if he was for industry, why wasn't there one for patients? I didn't see a response to that question.