FDA Proposes Stent Guidelines

Lauren Ellerman

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Wallstreet Journal reported today that the FDA has proposed tougher clinical guidelines for drug coated stents, in response to concerns that stents have unknown side effects. The new regulations require follow up data be submitted to the FDA 1 and 2 years after implant.

Well I believe that more data could be helpful - but here is the odd part - FDA guidelines ARE NOT legally binding. It may help in the approval process to follow them, but there is no requirement that the data be collected and sent.

So again - reports of blood clots and heart attacks, and we get a flexible guideline.