Proposed Rule Submitting Labels Electronically

On October 17, 2016, FDA-CDRH issued a proposed rule on Electronic Submission of Labeling for Certain Home-Use Medical Devices

You may see the comments to the docket at The Docket Number is FDA-2016-N-2491.

Under the proposed rule, which affects Part 807, medical device establishments listing devices labelled for home use would submit the device label and package insert in an electronic format to FDA. FDA plans to make this device labeling information available to the public through an FDA-managed or partner Internet Web site.

The electronic submission would cover Class II and Class III “home use devices” defined as a medical device labeled for use outside a professional health care facility. The proposed rule would allow voluntary electronic submission for Class I devices.