News Feature | October 1, 2014

FDA Must Follow Congressional Procedures When Rescinding 501(k) Clearance

By Nick Otto


The FDA’s ability to reclassify devices was restricted by a federal appeals court, which issued a ruling that says the agency does not have the inherent authority to reclassify devices.

Rather, the U.S. Court of Appeals for the District of Columbia says in its recent ruling that the FDA must follow Congress’s procedural requirements when reclassifying devices.

In a 2-1 decision, the court ruled in Ivy Sports Medicine v. Burwell that the FDA cannot override the statutory medical device reclassification process by rescinding a 510(k) decision in what the FDA called an exercising of its “inherent reconsideration authority.”

“The Court of Appeals generally analyzed the federal agency’s ‘inherent authority’ to revisit a prior decision,” according to FDA Law Blog. The Court of Appeals explained that the agency’s “inherent reconsideration authority does not apply in cases where Congress has spoken.”

“Under the statute, the FDA must take certain procedural steps to rescind its approval, including a notice and comment period,” according to Courthouse News Service.

The agency asserts it does in fact have the authority to change its mind about the “substantial equivalence” of devices, according to the ruling. In this case, the agency’s new determination that the collagen scaffold lacks a substantially equivalent predecessor meant it was automatically put into Class III.

The lawsuit stems from an FDA approval of the mesh — called the collagen scaffold — in December 2008. But “the process had been tainted by improper pressure from other members of Congress,” according to the ruling. The following month, the agency decided because the approval process had been flawed with “procedural irregularities,” and due to the focus of extreme political pressure, the device’s approval was eventually revoked.

FDA Law Blog explains that the court’s majority says the ruling is narrow and “only relates to the rescission of a 510(k) substantial equivalence determination when it results in the de facto reclassification of a device,” adding that it remains to be seen if the recent ruling will be applied to past instances when the agency rescinded other 510(k) clearances to “correct” approval mistakes.