"FDA, You Failed Me" (LinkedIn - Medical Devices Group)
Frequent group contributor 89-year-old Dr. Robert Christensen has a story to tell. And a plea for change. These are his words. He writes,
"Back in 1960, I invented and commercially sold the first implantable device for temporomandibular joint disorder (uncontrollable teeth grinding). In our best year, we did $5
million in sales.
My device was grandfathered in 1976 from the Medical Device Regulation Act which introduced medical device classifications. In 1993, FDA classified mine as Class III... then, in 1998, demanded a pre-market approval (PMA) on my device which had nearly 40 years' in-market experience!
I fought and won. But lead FDA investigator (Dr. R) was looking for millions in government grants to study TMJ disorder. She also had ties to my competitor (TMJ Concepts). Eventually, a corrupt system bankrupts me.
Dec-98: FDA requests a PMA of my company, TMJ Implants (TMJI).
May-99: Dr. R asks me to skip my panel meeting. I attend anyway.
May-99: TMJI wins a 9-0 vote for approval in Wash, D.C.
Jul-99: Dr. R calls and states my devices were not approved and demands a 510(k). I am to discontinue operations and marketing. I ...
