Sometimes I wonder if the FDA sucks as much as I think the FDA sucks.
And, it turns that it DOES.
An article, "Medical Devices: Lost in Regulation," by retired medical device researcher Paul Citron in the Spring 2011 Issues in Science and Technology [downloadable here] argues:
Although the United States is still home to numerous medical device companies, these companies no longer bring cutting-edge innovations to U.S. patients first. And U.S. clinical researchers now often find themselves merely validating thea pioneering work that is increasingly being done in Europe and elsewhere in the world. Worse still, seriously ill patients in the United States are now among the last in the world to receive medical innovations that have secured regulatory approval and clinical acceptance elsewhere in the developed world.
Citron cites several cases in which European patients benefited from early access to new medical devices: Deep brain stimulation to treat Parkinson's disease by 44 months; a ventricular support device to improve circulation by 29 months; a pacemaker device to manage irregular contractions in failing hearts by 30 months. Why is this happening? Citron maintains:
What's behind this erosion of leadership and late access to innovations? Simply stated, an overreaching, overly burdensome, and sometimes irrelevant Food and Drug Administration regulatory process for the most sophisticated new medical devices.
(Nod to Angry Alex)