FDA revisits earlier proposal to add prescribing information to device labelling
This article was originally published in Clinica
Executive Summary
The FDA has decided to look again at medical device labelling. Two years ago the US agency put out a guidance recommending that companies add a brief abstract of key prescribing information in the labelling. The abstract, known as essential prescribing information, was intended to give practitioners a quick overview of the contents to be found in the full labelling.