“FDA, You Failed Me” by Dr. Robert Christensen

"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 appro...