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Contrast Agents Regain ‘Drug’ Status, But Ophthalmic Products Still Subject To Genus Decision

 
• By Brenda Sandburg

Legislative rider effectively reverses Genus court ruling, and now US FDA must treat contrast agents, radioactive drugs and OTC monograph drugs as drugs. However, the agency will have to assess case-by-case whether certain ophthalmic products meet the definition of ‘drug’ or ‘device.’

drug -device designations
Certain products to be regulated as drugs rather than as devices under omnibus year-end legislation. • Source: Shutterstock

The US Food and Drug Administration succeeded in getting Congress to undo a court ruling that prompted the agency to start transitioning certain products regulated as drugs to device status. The omnibus government funding legislation that cleared Congress at the end of December included a rider specifying that “any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug” and not a “device.”

As a result, the upheaval in this space will be averted and regulation of these products will go back to as it was prior to a decision by the US Court of Appeals for the District of Columbia in Genus Medical Technologies LLC v. FDA

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