Since the US FDA released a proposed rule for its new Quality Management System Regulation in February 2022, the agency has been steadfast that it would publish the final rule before the close of 2023 despite much skepticism. Now with that deadline fast approaching, will the agency prove skeptics wrong?
For some time now, the Food and Drug Administration has been looking to mesh its Quality System Regulation (QSR) with international standards for medical device quality management systems.
Specifically, the agency plans to replace QSR with a new document, the Quality Management System Regulation, or QMSR, which will...
The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
