Idea #315 for December 30th, 2009: Passing Muster or Stricter Device Approval Guidelines At The FDA

The FDA has announced plans to implement a more strict process for the approval of medical devices. This decision comes after several journal articles brought to light flaws in the current approval process. For instance, an article in JAMA showed that the approvals of a number of cardiovascular devices in the last decade were based on a single study. Also, only about half of the outcomes in the studies were compared to control groups. Rigor has certainly been lacking in these FDA approvals. It might be a case of too little, too late, but at least the FDA has admitted to the problem and will make an effort to address it.

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