Drug or Device? Manufacturers See Burden in FDA Reclassifying

Patients could face disruptions in medical treatment if the FDA moves ahead with plans to regulate some products as devices instead of drugs, according to manufacturers who decry the shift as onerous and time-consuming.

The Food and Drug Administration is reviewing whether certain products long regulated as drugs—such as contrast imaging agents patients take before MRI or CT scans to provide clearer images—will need to transition to device status. The agency’s announcement was a win for manufacturers seeking device status for new products, as it is much more expensive to develop and market a drug than a device.

But industry ...