FDA to Make Case for Standard Labeling at April Public Workshop

The FDA will hold an April 29 workshop on device labeling at its White Oak, MD., campus, as part of an ongoing effort to ensure that labeling is accessible and useful. The agency is concerned that there are no regulations explicitly describing standard content and format for device labeling. In addition, there is no single database of medical device labeling to which people can refer when using a device that does not have easily accessible labeling. Both of these factors could increase the risk of error, the FDA says.
The GMP Letter