It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.
Check out Medtech Insight's US FDA Warning Letter Data Tracker here.
This chart lists medical device-related warning and close-out letters posted online by the US Food and Drug Administration in September 2023. The agency's close-out program publicly indicates when a manufacturer...
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
