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.
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]).
Aug 31st, 1997