On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...

"FDA’s UDI guidance ‘ambiguity’ could lead to inconsistent implementation" was originally created and published by Medical Device Network, a GlobalData owned brand.

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s neuromuscular ...

The Food and Drug Administration recently released finalized guidance for medical device labelers for submitting data to the Global Unique Device Identification Database. A draft version of the ...

The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018. The newly ...

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug ...

A recent study led by researchers at the Yale School of Medicine and Harvard Medical School found that a loophole in existing regulation has allowed manufacturers to acquire U.S. Food and Drug ...

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA's most serious recall, the agency announced Monday. The recall comes years after surgeons say they ...