FDA has put out a call for makers of home-use medical devices to consider participating in a pilot program that would create an online searchable database of labeling and package inserts about their devices. The home-use device labeling pilot program is intended to become a resource for patients and caregivers using devices at home.
In a Federal Register notice published Monday, the agency's Center for Devices and Radiological Health (CDRH) noted that it wants to create such a resource because home-use devices are often used by untrained lay people, instructions and labeling for such device may easily become lost or discarded in the home setting, and up-to-date information for older devices may no longer be available on company websites.
This database would fill the holes for device labeling and package inserts and make it possible for users to search for different types of legal home-use devices and find information about devices they use or plan to use.
FDA is asking for up to nine volunteers, makers of medical devices that are labeled for home use. After volunteers are recruited in May, the pilot participants will submit device labels and package inserts through the CDRH electronic submissions system. FDA will not be evaluating the labeling content, but will be asking participants to give feedback on the submission process and usability for the duration of the six month pilot, from July 1–December 31, 2015.
This pilot program is one component of FDA's Medical Device Home Use Initiative. This labeling pilot program was preceded by a preliminary labeling repository pilot in 2011 and a public meeting in 2013 on the topic.
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