"Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax," reports this New York Times news article, "Quickly Vetted, Treatment Is Offered to Patients." In general, the 510(k) process is intended to be a quick-review process that promotes innovation, and that most new devices improve upon an existing device so there is rarely is a need for full review.
Read the article for yourself. Some controversial issues are raised that you might be interested learning about. You be the judge.
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Thursday, October 30, 2008
Medical Devices - A murky 510(k) world?!
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