> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bill to Tighten Device Signal Communications
- URL: https://www.fdaweb.com/bill-to-tighten-device-signal-communications/
- Published: 2022-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:47:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152006

Sens. **Roger Marshall** (R-KS) and **Mike Braun** (R-IN) have introduced S. 4349 to amend the Federal Food, Drug, and Cosmetic Act to add limitations on how notifications are made about potentially harmful medical devices. The [bill](https://www.congress.gov/bill/117th-congress/senate-bill/4349/text?q=%7B%22search%22%3A%5B%22%5C%22food%2C+drug+and+Cosmetic+act%5C%22%22%2C%22%5C%22food%2C%22%2C%22drug%22%2C%22and%22%2C%22Cosmetic%22%2C%22act%5C%22%22%5D%7D&r=3&s=2&ref=fdaweb.com) says that any such notification should include a description of the applicable device or devices and should reflect “the totality of the evidence on which the notification is based and information about the known benefits and risks of the device or devices, including information from the manufacturer or manufacturers.”

The bill also provides that if contradictory scientific evidence is presented to FDA, that evidence should be included in any notification “in a manner that provides the intended audience with a complete understanding of the overall nature of information concerning the potential risk.”

The bill would require that manufacturers be told of issues that are going to be included in a notification and have an opportunity to comment and provide information that could be considered by FDA before a notification is issued.