In Case You Missed It: Top 10 "Gray Sheet" Stories In October

Our most popular stories last month focused on how device firms respond to FDA inspection reports; guidelines from the agency on how to handle manufacturing site changes; product labeling matters; and off-label marketing rules, among other topics.

Our analysis of survey data exploring how manufacturers respond to FDA Form-483 inspection reports was the most popular item on "The Gray Sheet" website

in October.

More from Regulation

More from Policy & Regulation

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

Global Medtech Guidance Tracker: May 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.