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Is lack of standardized medical device labeling harming patients?

The FDA is studying if they should require standardized medical device labeling.

The FDA will begin a study to look at whether or not they should require standardized medical device labeling.

The study, announced in September 2014, and expected to begin soon after a comment period, will involve two hospitals and several dozen healthcare practitioners, according to an article on the Regulatory Affairs Professionals Society.

"…we propose to measure the usability and usefulness of a draft standard content and format of device labeling against existing manufacturer labeling of the same device," the FDA said in their Federal Registry notice. "Findings will provide evidence to inform FDA's planned regulatory approach to standardizing medical device labeling across the United States."

According to the Regulatory Affairs Professionals Society, "there's no single repository for medical device labels. While such information is easily available for all pharmaceutical products, differences in device labeling formats make it difficult to collect and compare such information."

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