Medical device labeling update

FDA's Office of Device Evaluation is holding a public meeting in September to discuss medical device labeling and the agency's proposed labeling information summaries (tentatively called "essential prescribing information" [EPI]).

Susan Alpert, director of the Office, said adding EPI to labels would not require new labeling information. The goal, she said, is to find a better way to package critical product information so that it is more likely to be seen and read by consumers, many of whom currently don't read labels.

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