Home-use medical devices. Medical equipment (ICS: 11.040)

Electronic Submission of Labeling for Certain Home-Use Medical Devices (13 pages, in English)

The Food and Drug Administration (FDA) is proposing toimplement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) torequire electronic submission of the device label and package insert of certain home-usedevices when these devices are listed with FDA. FDA plans to make this device labelingavailable to the public through the Internet and would also provide search tools to facilitatelocating information concerning a particular home-use device or a particular type of homeusedevice.