The agency unveils its plan to improve medical device labeling and packaging for 2013, starting with a public workshop.
CDRH plans to unveil an outline for standardized medical device product labeling at an April 29 public workshop exploring drug-like labeling formats for devices. “The purpose of this public workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible,” an agency notice says.
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.