FDA Seeks Participants for Pilot Home Use Device Labeling Database

April 17, 2015

The U.S. FDA’s Center for Devices and Radiological Health is launching a public database of labeling for home use devices and is looking for devicemakers to help test it later this year.

The goal of the CDRH Home Use Labeling Pilot program is to improve the safety of medical devices that are used in the home, the FDA says, noting that people may lack specific training in use of a device and are more dependent on the labeling and package inserts than medical professionals. Moreover, if the device is used over a period of years, the original labeling may be lost or not reflect updates to safety information and instructions for use.

Some manufacturers address this concern by putting safety information on their websites, the FDA acknowledges. Those sites often focus on newer products and don’t include information on older models or products no longer being sold. Further, most manufacturers don’t post all labeling and package inserts for every device they have listed, the agency says.

The CDRH database will include information on labels and package inserts for all home-use devices. Consumers will be able to access the database through the FDA website and search for information on specific devices.

During the pilot, participants will be asked to test the electronic submissions process and practice submitting labels and package inserts in PDF format. Company feedback will be used to evaluate the database. Submitted packaging and labeling will not be evaluated for potential regulatory concerns and the database will be private during the trial, the FDA says.

Companies interested in participating in the project may apply throughout the month of May. The program will run from July 1 through Dec. 31.

For information, contact Mary.Brady@fda.hhs.gov. No more than nine manufacturers will be asked to participate.

View the announcement at www.fdanews.com/04-20-15-homeuse.pdf. — Elizabeth Orr