Grapefruit USA Inc (GPFT)

[Homer Simpson]

The FDA seems to be doing a terrible job of approving devices that actually work !!

http://articles.baltimoresun.com/2011-02-24/news/bs-ed-fda-regulations-20110224_1_diseased-heart-valves-cardiology-fda

A study conducted by John Makower, consulting associate professor at Stanford's Biodesign Innovation program, demonstrated that the FDA delays approval by two years, on average, for low-to-medium-risk medical devices, compared with Europe; approval of high-risk devices in the U.S. took 31/2 years longer than in Europe.

Perhaps in response, the FDA finally announced this month its openness to considering reforms to the review process for innovative medical devices. The current premarket review process for new medical devices has been fraught with uncertainty, often requiring companies to produce further unanticipated testing and data for proven products. Regulations force device manufacturers to replicate time- and cost-consuming studies in the U.S., despite the existence of reputable equivalent scientific data gathered overseas.

In contrast to the FDA, the European Medical Devices Directive allows privatized, notified bodies to test device safety to provide the stamp of European market approval.

Last week, the House Energy and Commerce Committee's Subcommittee on Health held a hearing on medical device regulations. In his testimony, Mark Deem of San Francisco Bay area medical device incubator The Foundry blamed the unpredictability of FDA regulatory delays for driving U.S. business to Europe.

"We develop our products here and then run the same large, multicenter randomized trials we would otherwise have conducted in the U.S. overseas," he said. "We are then staying [in Europe] to commercialize the products while we decide when and if to approach the FDA."

Much of the bureaucracy inherent in the FDA approval process has been driven by calls for increased patient safety. However, despite the speed of the privatized European device approval process, there have been no sacrifices in patient safety. A report by the Boston Consulting Group released earlier this year found that the medical device recall rate was similar in the U.S. and Europe.