In general, 510(k) exempt medical devices do not require premarket review because the FDA has determined that they are substantially equivalent to another legally marketed device. For example, the 2012 510(k) premarket approval for two newly introduced variations of the Cook Celect IVC filter is based on their similarity to a Cook Celect IVC filter already in interstate commerce. Previous versions Cook Celect devices were approved as similar to Cook’s even older Gunther Tulip design. The new devices draft behind the old ones to speed to market.
Two things can go wrong with this approach: either the new product is not substantially equivalent to the old one or the old one was not safe, in the first place.
The FDA has issued extensive guidance about how the determination that one device is “substantially equivalent” to another is made. The review is animated by, among other things, the “least burdensome principle.” This principle limits the FDA’s inquiry into the smallest subset of issues necessary in order to establish that a new device is similar to an existing one.
It is designed to reduce the burden on applicants for approval and the reviewers of applications -- not the burden of illness and permanent damage to the health of patients. That is ostensibly accomplished with the first FDA approval, which may have become long buried under repeated fast-track applications based on the predicate of a predicate of a predicate device. What is the remedy when the first assumption proves to be false?
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Neither the inquiry nor the response touches on the larger question of how patients are protected during the long period that may precede the recall of the predicate device. The inference that the flaws in the FDA’s fast-track approval process may be a part of the problem for IVC filter plaintiffs remains troubling.