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FDA’s Controversial 510(k) Process Under Scrutiny

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The FDA has tightened up the standards of its controversial 510(k) program by limiting the scope of how medical device makers can market new products to consumers. But the program itself has remained intact, and medical device companies continue to have an avenue to fast-track product development without being required to conduct extensive testing and clinical trials.

What is the 510(k) Program?

The 510(k) program allows device manufacturers to continue to bring products to the market without a full range of testing and study, allowing newly developed medical devices to bypass clinical trials and testing if they are proven to be “substantially equivalent” to others already on the market. The first device of its kind is known as a “primary predicate device,” must still undergo rigorous testing.

In some cases in which a device has the same intended use as one predicate device and the same technological features as another predicate device, manufacturers have attempted to push approval of these split-predicate products, but with the new guidelines, this procedure will be inconsistent with the 510(k) process, and those devices will not gain approval, according to the FDA.

Lariat Fast-Tracked for Approval

One product that was fast-tracked to become available to consumers but is currently under fire is the Lariat, a snare-like surgical tool made by SentreHEART. The Lariat was FDA-approved for soft tissue closure only, but is also being used to close off the left atrial appendage, a small sac in the heart thought to be the source of blood clots that can lead to strokes in patients with atrial fibrillation. This off-label use has led to urgent surgery and even death in some cases.

The Lariat’s main competitor is The Watchman, a product that went through nearly a decade of rigorous testing and was specifically approved by the FDA for this specific purpose.