Is The FDA Too Lenient When Reviewing Medical Devices?
I speak to people in the pharmaceutical industry much more than folks who develop medical devices. I know how pharma researchers spend years and hundreds of millions of dollars trying to develop a useful, safe new drug that the FDA will approve for marketing. Certainly there are big payoffs, but the road is filled with potholes and trapdoors and the analysis by the FDA is rigorous.
But for years we’ve been hearing that it is much less rigorous when it comes to medical devices. Artificial hip joints and stents to open blocked arteries fall into this category. And recently, the less stringent review process has been highlighted in the news. Metal-on-metal hip joints are being removed from patients who had them implanted. They thought Read more »
*This blog post was originally published at Andrew's Blog*
