James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360, in “FDA Wants Oversight of Lab-Developed Tests,” by Kelly Lienhard. (Read the full version – subscription required.)

Following is an excerpt:

The U.S. Food and Drug Administration moved to classify laboratory-developed tests as medical devices on Friday, marking a momentous decision after more than a decade of debates over whether the tests should be subject to more oversight from the regulatory agency.

The FDA's new proposed rule would phase out its current hands-off approach to regulating laboratory-developed tests and begin require laboratory test manufacturers to meet the same standards as other in vitro diagnostic products. …

James Boiani, an attorney at Epstein Becker Green, told Law360 on Friday that Congress and the courts are likely to get involved since the FDA decided to take a "forceful first step" toward regulation by proposing the rule.

Boiani says the FDA's proposed rule takes a more aggressive stance than in the past on making a case to regulate by hitting back on the innovation argument, specifically stating that the "scheme is in some cases fostering unfounded claims of innovation rather than responsible innovation."

"This is really throwing the gauntlet down in regulatory law speak," Boiani says. "I think it speaks to FDA frustration with prior proposals getting knocked back, and strategically, their approach to restarting the LDT conversation is a strong one."

Moving forward, the FDA is asking for stakeholder feedback on a number of issues within potentially regulating LDTs, including the exclusion of tests developed in academic labs and whether tests already on the market should be grandfathered in.

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