FDA Clearance Process Lesson Learned

As a young medical device lawyer I realized I didn’t understand the FDA’s role in clearing medical devices. I had a lot to learn. FDA Clearance Process Lesson Learned Consulting Doctors Stand To Make Lots Of Money

No Clinical Testing Required

What I would find out is that manufactures of medical devices are able to market new medical devices without clinical testing. These are devices that are implanted in the human body. This happens because of the FDA’s clearance process. The process goes something like this:

  • Develop a product, then
  • Choose another product, with similar specifications and uses, for comparison
  • Send in the paperwork to the FDA saying your product is just like someone else’s (so why waste time with clinical trials?)
  • You prepare to market your product to the American public
  • Hide behind the public’s misunderstanding of the FDA clearance process if the “you know what” hits the fan.

Consulting Doctors Stand To Make Lots Of Money

What really hit home though was finding out consulting doctors involved in the process above stand to earn millions once the device hits the market. So, yes, time (as in loopholes) means money. Combine that with the additional fact that even if the product upon which you based your device for clearance is ultimately recalled by the FDA, that recall has no effect on subsequent devices!

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No Additional Testing Required

To say it another way if the FDA agrees with you that your device “B” is substantially equivalent to another cleared device called “A” you can market B without clinical trials. And if “A” is recalled because it hurts and even kills patients, that recall has no impact on whether B stays on the market. That’s right, the FDA doesn’t even tell the manufacture of B that maybe clinical trials should be conducted to test the safety of B.

This is bad stuff if your concern is patient safety. If, however, you believe the human body is really just a vessel for corporations to put stuff in, then this is great!