Medical Device Labeling: CDRH Plans Drug-like Labels for Devices

FDA says it is concerned that the lack of standard content and format may translate into increased medical device errors. “Also, there is no single available labeling source for people to view, search, and download for devices that are used in clinical and non-clinical environments,” the notice says.

Key findings from a recent research survey helped create the new outline for standard content and format for medical device labeling that identifies the most relevant sections, the agency says. The survey also called for a condensed labeling version to act as a quick reference for safe and effective device use, which will also be discussed at the workshop.