The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...

Medical device recall events in 2024 reached their highest level ... It’s largely because the agency is working to improve ...

The FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device ...

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...

The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...

More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...

Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE ...

Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...

Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...

Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...