The rule further permits the use of the statements “Rx only” and “℞ only” for prescription devices and also requires standalone symbols to be explained in a paper or electronic glossary included with the device.
While the FDA previously required companies to have explanatory text accompany any standalone labels, pressure from the medical device industry — who saw the old method as inefficient — pushed the agency to issue a proposed rule to allow standalone symbols in 2013.
Although the standalone rule is optional for drug companies, the FDA estimates the resulting reduced workload will produce annual savings of up to $25.5 million.
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