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

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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

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medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...

Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...

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, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...

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medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...