FDA medical device proposal may skirt the law: legal experts

(Reuters) - A proposal by the U.S. Food and Drug Administration to create a new fast-track path to market for medical devices may exceed its authority and require some creative reasoning to justify, legal experts said.

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

FDA Commissioner Scott Gottlieb last week proposed the creation of a quick route to market for certain products that may not meet the criteria for clearance under the agency’s existing fast-track pathway, known as 510(k), saying it would foster innovation.

The proposal is part of a broader effort by the FDA to reduce the amount of clinical evidence required for medical device approvals and is in keeping with President Donald Trump’s vow to cut regulations. If implemented it could save device companies millions of dollars and shave years off development times.

Under current law, a product cleared under the 510(k) pathway must show substantial equivalence in materials and intended use to an existing legally marketed device, known as a predicate. Roughly 3,000 devices are cleared this way each year, making it by far the most common route for a medical device to reach the market.

The new proposal would dispense with the need to test a new product against a specific predicate. The benchmark would instead be a set of technical standards that would, in effect, serve as a proxy for the predicate.

The agency plans to release further details in non-binding guidance for industry early next year.

Donald Migliori, a lawyer with Motley Rice LLC who represents victims of defective medical devices and drugs, said the agency appears to be “regulating the law away by providing an alternative path for companies that may be far more attractive for them.”

The FDA will have to get creative with the wording of its guidance if it hopes to justify the move legally, said Bethany Hills, a lawyer who chairs the FDA practice at Mintz Levin and represents device makers filing applications with the agency.

One option, she said, would be for the FDA to try to stretch the definition of “predicate” to mean a set of technical standards common to a basket of products in the same class.

Lars Noah, an expert in medical technology and public health law at the University of Florida, doubts the argument would hold up under legal scrutiny.

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


It is unclear, however, whether any private party would actually challenge the FDA since most companies would likely benefit.

Dr. Jeffrey Shuren, head of the FDA’s medical device division, said in an interview that the move would simply expand on something the agency is already doing with it’s 20-year-old, rarely-used “abbreviated” 510(k) pathway.

The abbreviated route allows companies to show their device meets certain product standards but does not eliminate the need for a specific predicate. Shuren said companies in future could show substantial equivalence “to a technology” rather than a product.

In some ways the new proposal mimics a now frowned-upon practice known as “predicate stacking” in which companies would include multiple predicates in their application. The new product might contain characteristics substantially equivalent to a conglomeration of predicates but not a single product.

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

Another option the FDA could take to cling to the law might be to say the proposal is experimental and therefore subject to greater legal wriggle room, Hills said. The agency took this route when it announced in September that it would launch a pilot program for digital health products aimed at speeding innovation in the field.

Nine companies, including Apple Inc Roche Holding AG and Johnson & Johnson 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 said. “That boggles my mind a bit.”

Reporting by Toni Clarke in Washington; additional reporting by Tina Bellon; Editing by Susan Thomas