Check out Medtech Insight's US FDA Warning Letter Data Tracker here.
This chart lists medical device-related close-out letters posted online by the US Food and Drug Administration in September 2022. The...
Warning Letter Close-Outs – September 2022
The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.
More from US FDA Warning Letters
More from Compliance
• By
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.
• By
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.
• By
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.