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Medical Device Approval and the 510(k) Process

In an article about what the FDA does not tell you, Smart Money tells us that 90% of medical devices approved by the FDA go through what is called a “510(k)” which allows device manufacturers to skip testing a device before putting it on the market if there is already a “similar device available.”

I’m not saying necessarily that every medical device that has the slightest modification should have to jump through the full FDA approval process. I think few people really say that. The question is simply where do we draw the line and it seems fairly clear that we are drawing it in a way that makes it far too easy on medical device manufacturers.

The FDA recently took a shot at making the 510(k) device clearance process “more predictable and smarter” but has not made any real progress. Again, I understand their trepidation. We want to get products with slight improvements in the market quickly. I just think we have to (1) better define what qualifies for 510(k) and (2) intensify the requirement – something in the middle of full-blown testing and “bring it on through.”