"Rx only" labeling
This article was originally published in The Gray Sheet
Prescription device labeling would be allowed to state "Rx only" in place of the currently required legend: "Federal law restricts this device to sale by or on the order of a [type of licensed practitioner]," under guidance currently being drafted, agency staffers say. The change, which the FDA Modernization Act allowed for drugs, was advocated for devices in a March 1 citizen petition filed on behalf of the Contact Lens Institute. The Rx symbol facilitates "a less cluttered label and international uniformity and simplicity," the petition states. FDAers note that the labeling change likely would not apply to in vitro diagnostic devices, which are subject to separate regulation
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