Report: Proposed new FDA rules might not be legal

A new regulatory pathway for medical device proposed this month by the FDA might fall outside the safety watchdog’s authority, legal experts told Reuters.

The voluntary alternative would allow clearance upon demonstration equivalence by meeting objective safety and performance criteria, the FDA said Dec. 11. Under the new framework, device manufacturers would be asked to meet objective criteria based on FDA-developed standards or guidance documents which “embody the safety and performance criteria that new devices could meet to be cleared under a 510(k).”

The new pathway would be available for pre-specified categories of devices, limited to devices which have enough safety and performance criteria to be ably identified. Draft guidance on the new pathway is slated to be released in the first quarter of 2018, the FDA said.

But legal experts told Reuters that the proposal might not be legal and would require some fancy footwork to justify.

Motley Rice attorney Donald Migliori, a plaintiff’s lawyer in product liability lawsuits, said the FDA appears to be “regulating the law away by providing an alternative path for companies that may be far more attractive for them.”

Creative wording in the forthcoming guidance will be necessary to justify the move legally, added Bethany Hills, chairwoman of the FDA practice at Mintz Levin. One way to do that would be to stretch the definition of “predicate” to cover a set of technical standards shared by a group of products, Hills told the wire service.

But another medtech and public health law expert, Lars Noah of the University of Florida, said he doubts that argument would hold up.

“If somebody with standing wanted to challenge the FDA’s decision in court, a judge is going to say, ‘Show me the predicate,'” Noah said. “I don’t see how the court would side with the agency.”

Dr. Jeffrey Shuren, head of the FDA’s Center for Devices & Radiological Health, told Reuters that the proposed pathway expands on the 20-year-old, rarely-used “abbreviated” 510(k) route, in which devices must meet product standards and cite a specific predicate device. The new proposal would allow companies to show substantial equivalence “to a technology” rather than a product, Shuren said.

The new proposal is akin to “predicate stacking,” where companies cite several predicate devices, in that a new product might contain characteristics substantially equivalent to a number of predicates rather than a single product.

“The FDA got nervous about stacking, because we weren’t comparing a device to a device,” Hills explained. “It sounds like now they are going to consolidate the predicates just like we used to do when we stacked them.”

Another option would be to say the proposal is experimental and therefore subject to greater leeway, she added. The agency took this route when it proposed a pilot program for digital health products aimed at speeding innovation.

Nine companies, including Apple (NSDQ:AAPL), Roche (PINK:RHHBY) and Johnson & Johnson (NYSE:JNJ), will be pre-certified based on certain quality and technical metrics to release new digital health products without filing a 510(k) for each.

“These companies will work with FDA to waive the statutory obligation to file a 510(k),” Hills told Reuters. “That boggles my mind a bit.”

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