FDA to Hold Workshop on Device Labeling

The U.S. Food and Drug Administration (FDA) has announced a public workshop to be held on April 29-30. Under discussion will be standardizing the format and content of medical device labeling and the development of a public repository or database that would provide access to medical device labeling. Regulators said the agency is concerned that the lack of standardized content and format and access to medical device labeling may increase the risk of medical errors. But by the same token, standardization and public access to medical device labeling raises several potential regulatory concerns (e.g., the ability to make modifications to the labeling) and could have product liability implications. Therefore, the FDA recommends that clients pay close attention to the agency’s proposals and developments on the issue and consider submitting comments.

Device “labeling” refers to any printed material on any medical device or any of its containers or wrappers, or on any material accompanying a device such as a guide or manual.

The meeting will be held at the FDA’s White Oak campus in Silver Spring, Md., and also will be webcast. The agency is seeking input and comments on the following discussion topics:

• Summary of the FDA’s work on labeling;
• Standard content and format of device labeling; and
• Repository of medical device labeling for home use devices.