US FDA data shared with Medtech Insight show that the number of quality-related warning letters sent to device manufacturers in calendar year 2021 ticked up 33% from 2020. Last year’s enforcement missives were also the most handed out by the agency in four years.
As the US Food and Drug Administration grappled with conducting on-site facility inspections in calendar year 2021, agency data show that the number of quality-related warning letters sent to device makers ticked up 33% from the prior year.
The FDA told Medtech Insight it mailed 28 quality-related enforcement missives to device makers last year – seven more than...
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.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
