Court rules that FDA cannot rescind 510(k)s without notice and comment procedures

ReGen Biologics' Collagen Scaffold--Courtesy of ReGen Biologics

The FDA's powers to reclassify devices were restricted by a federal appeals court ruling that said the agency does not have the inherent authority to reclassify devices. Rather, the FDA must follow Congress's procedural requirements when reclassifying devices, including notice and comment procedures.

The D.C. Circuit's U.S. Court of Appeals vacated the FDA's reclassification of ReGen Biologics' Collagen Scaffold (a resorbable mesh implanted inside the knee joint in treatment of injuries of the meniscus) from Class II to Class III on Sept. 26, meaning it would require a PMA instead of a 510(k). It overruled a 2013 decision in favor of the FDA from the United States District Court for the District of Columbia.

"Because reclassification must be done 'by regulation,' (under the Food, Drug, and Cosmetic Act) it must be done in accord with certain procedural requirements, including notice and comment," the appeals court ruled. "Put more simply, our cases assume that Congress intends to displace an administrative agency's inherent reconsideration authority when it provides statutory authority to rectify the agency's mistakes," the ruling continued.

The FDA argued that it has the authority to change its mind about the "substantial equivalence" of devices. 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 court didn't buy the FDA's argument, however, saying that "as a practical matter, the decision to revoke a substantial equivalence determination in circumstances like those present here is a de facto reclassification of the device into Class III, at least absent other FDA action."

In addition, the agency pointed out the product's controversial past. The reclassification was made following an internal investigation, which concluded that the previous Class II designation was a result of pressure from Congress. From 2005 to 2008, the FDA decided three times that the scaffold did not have a substantially equivalent predecessor device. But following letters lobbying for ReGen from New Jersey's congressional delegation, the agency decided around early 2009 that the scaffold did have a substantially equivalent device and put it in Class II.

The FDA now seeks to regulate the Collagen Scaffold as a Class III device, but the court said that the improprieties in the decision-making process were not that severe and do not justify reclassification outside of the statutory guidelines.

The ruling holds only in cases where the rescission of a 510(k) would result in a de facto reclassification, according to the FDA Law Blog. "It remains to be seen if this ruling would apply to FDA's presumed inherent authority to rescind a 510(k) substantial equivalence determination so long as the device remained a class II device, and the 510(k) holder was merely required to submit a new 510(k) for the device," wrote Hyman, Phelps & McNamara attorney Allyson Mullen on the website.

She added that "it remains to be seen if this decision will act as a check on other instances where FDA has asserted that it has the inherent authority to 'correct' mistakes involving other product approval decisions and exclusivity matters. We have seen a number of such decisions in the drug approval arena."

- read the decision (PDF)
- here's analysis from the FDA Law Blog

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