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Ophthalmic Dispensers Recommended Class I Designation By FDA Panel

…and the first tangible impacts of the Genus vs. FDA decision

 
• By Hannah Daniel

The FDA’s Ophthalmic Devices Panel approved a Class I designation for ophthalmic dispensers, which were reclassified from drugs to devices after the Genus v. FDA decision.

• Source: Shutterstock

The US Food and Drug Administration’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee recommended a Class I designation with general controls for ophthalmic dispensers.

Ophthalmic dispensers such as eye droppers or eye cups are manual devices meant to hydrate or

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