Electronic Submission of Labeling for Certain Home-Use Medical Devices
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
October 17, 2016
Last updated
October 17, 2016
Description
Document number 2016-25026. The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through the Internet and would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)