FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems


FDA Spinal Device

FDA Wants Continued Studies of Spinal Systems

FDA is requiring postmarket surveillance studies for the manufacturers of 16 dynamic stabilization systems that are implanted during spinal surgery. The agency continues to indicate that it is taking public health in a serious manner these days. FDA is doing so under Section 522 of the Food Drug and Cosmetic Act. This allows FDA to:

require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be-
(1) implanted in the human body for more than one year, or
(2) a life sustaining or life supporting device used outside a device user facility.

Why is this a big deal? Because currently there are only five active postmarket studies being conducted because of Section 522 and only three of them are for a “510(k)” approval that does not require extensive clinical studies of devices that require a “Pre-Market Approval” or PMA. Not only that, there are currently no 510(k) devices that have been implanted for more than a year.

It seems that postmarket surveillance is going to increase under Commissioner Margaret Hamburg and her principal deputy, Joshua Sharfstein. I certainly would want to know what is going to happen with a medical device implanted in me for a year. I think that most of us would agree that more postmarket surveillance with drugs as well as medical devices is called for.

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